Trial Outcomes & Findings for Radiosurgery in Treating Patients With Kidney Tumors (NCT NCT00458484)
NCT ID: NCT00458484
Last Updated: 2020-07-22
Results Overview
Dose escalation stops if 2/4 (50%) or 3/8 (37.5%) of participants experience DLTs in a given dose level cohort. The maximum tolerated dose will be one dose level below which the DLTs were exceeded.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
once every 4 weeks
Results posted on
2020-07-22
Participant Flow
Participants were recruited local hospital from 2/2007 to 5/2017.
Participant milestones
| Measure |
Series 1/Dose Level 1: Stereotactic Radiosurgery
Dose Level I: Radiation will be delivered in 4 fractions:
6 Gy x 4 fractions: Total of 24 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 1/Dose Level 2: Stereotactic Radiosurgery
Dose Level 2: Radiation will be delivered in 4 fractions:
8 Gy x 4 fractions: Total of 32 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 1/Dose Level 3: Stereotactic Radiosurgery
Dose Level 3: Radiation will be delivered in 4 fractions:
10 Gy x 4 fractions: Total of 40 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 1/Dose Level 4: Stereotactic Radiosurgery
Dose Level 4: Radiation will be delivered in 4 fractions:
12 Gy x 4 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 1: Stereotactic Radiosurgery
Dose Level I: Radiation will be delivered in 3 fractions:
16 Gy X 3 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 2: Stereotactic Radiosurgery
Dose Level 2: Radiation will be delivered in 3 fractions:
18 Gy x 3 fractions: Total of 54 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 3: Stereotactic Radiosurgery
Dose Level 3: Radiation will be delivered in 3 fractions:
20 Gy x 3 fractions: Total of 60 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
3
|
6
|
4
|
5
|
3
|
|
Overall Study
COMPLETED
|
4
|
6
|
3
|
6
|
4
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Series 1/Dose Level 1: Stereotactic Radiosurgery
Dose Level I: Radiation will be delivered in 4 fractions:
6 Gy x 4 fractions: Total of 24 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 1/Dose Level 2: Stereotactic Radiosurgery
Dose Level 2: Radiation will be delivered in 4 fractions:
8 Gy x 4 fractions: Total of 32 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 1/Dose Level 3: Stereotactic Radiosurgery
Dose Level 3: Radiation will be delivered in 4 fractions:
10 Gy x 4 fractions: Total of 40 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 1/Dose Level 4: Stereotactic Radiosurgery
Dose Level 4: Radiation will be delivered in 4 fractions:
12 Gy x 4 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 1: Stereotactic Radiosurgery
Dose Level I: Radiation will be delivered in 3 fractions:
16 Gy X 3 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 2: Stereotactic Radiosurgery
Dose Level 2: Radiation will be delivered in 3 fractions:
18 Gy x 3 fractions: Total of 54 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 3: Stereotactic Radiosurgery
Dose Level 3: Radiation will be delivered in 3 fractions:
20 Gy x 3 fractions: Total of 60 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Not eligible b/c prior radiation history
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Radiosurgery in Treating Patients With Kidney Tumors
Baseline characteristics by cohort
| Measure |
Series 1/Dose Level 1: Stereotactic Radiosurgery
n=4 Participants
Series I: Radiation will be delivered in 4 fractions: 6 Gy x 4 fractions total dose of 24 Gy.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 1/Dose Level 2: Stereotactic Radiosurgery
n=6 Participants
Series I: Radiation will be delivered in 4 fractions: 8 Gy x 4 fractions total dose of 32 Gy.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 1/Dose Level 3: Stereotactic Radiosurgery
n=3 Participants
Series I: Radiation will be delivered in 4 fractions: 10 Gy x 4 fractions total dose of 40 Gy.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 1/Dose Level 4: Stereotactic Radiosurgery
n=6 Participants
Series I: Radiation will be delivered in 4 fractions: 12 Gy x 4 fractions total dose of 48 Gy.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 2/Dose Level 1: Stereotactic Radiosurgery
n=4 Participants
Series II: Radiation will be delivered in 3 fractions: 16 Gy x 3 fractions total dose of 48 Gy.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 2/Dose Level 2: Stereotactic Radiosurgery
n=4 Participants
Series II: Radiation will be delivered in 3 fractions: 18 Gy x 3 fractions total dose of 54 Gy.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 2/Dose Level 3: Stereotactic Radiosurgery
n=3 Participants
Series II: Radiation will be delivered in 3 fractions: 20 Gy x 3 fractions total dose of 60 Gy.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
29 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
4 participants
n=21 Participants
|
4 participants
n=8 Participants
|
3 participants
n=8 Participants
|
30 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: once every 4 weeksPopulation: All participants who received treatment.
Dose escalation stops if 2/4 (50%) or 3/8 (37.5%) of participants experience DLTs in a given dose level cohort. The maximum tolerated dose will be one dose level below which the DLTs were exceeded.
Outcome measures
| Measure |
Series 1: Stereotactic Radiosurgery
n=19 Participants
Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 2: Stereotactic Radiosurgery
n=11 Participants
Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 1/Dose Level 3: Stereotactic Radiosurgery
Dose Level 3: Radiation will be delivered in 4 fractions:
10 Gy x 4 fractions: Total of 40 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 1/Dose Level 4: Stereotactic Radiosurgery
Dose Level 4: Radiation will be delivered in 4 fractions:
12 Gy x 4 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 1: Stereotactic Radiosurgery
Dose Level I: Radiation will be delivered in 3 fractions:
16 Gy X 3 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 2: Stereotactic Radiosurgery
Dose Level 2: Radiation will be delivered in 3 fractions:
18 Gy x 3 fractions: Total of 54 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 3: Stereotactic Radiosurgery
Dose Level 3: Radiation will be delivered in 3 fractions:
20 Gy x 3 fractions: Total of 60 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose of Radiosurgery
|
48 Gy
|
60 Gy
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 36 months from start of therapyPopulation: All participants who received treatment.
Radiographic efficacy as measured by overall (percent of participants still alive after study completion)
Outcome measures
| Measure |
Series 1: Stereotactic Radiosurgery
n=4 Participants
Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 2: Stereotactic Radiosurgery
n=6 Participants
Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 1/Dose Level 3: Stereotactic Radiosurgery
n=3 Participants
Dose Level 3: Radiation will be delivered in 4 fractions:
10 Gy x 4 fractions: Total of 40 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 1/Dose Level 4: Stereotactic Radiosurgery
n=6 Participants
Dose Level 4: Radiation will be delivered in 4 fractions:
12 Gy x 4 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 1: Stereotactic Radiosurgery
n=4 Participants
Dose Level I: Radiation will be delivered in 3 fractions:
16 Gy X 3 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 2: Stereotactic Radiosurgery
n=4 Participants
Dose Level 2: Radiation will be delivered in 3 fractions:
18 Gy x 3 fractions: Total of 54 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 3: Stereotactic Radiosurgery
n=3 Participants
Dose Level 3: Radiation will be delivered in 3 fractions:
20 Gy x 3 fractions: Total of 60 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
|---|---|---|---|---|---|---|---|
|
Overall Survival
|
75 percentage of participants
|
100 percentage of participants
|
33 percentage of participants
|
66 percentage of participants
|
66 percentage of participants
|
100 percentage of participants
|
66 percentage of participants
|
SECONDARY outcome
Timeframe: at 36 months from start of therapyPopulation: All participants who received treatment.
Percent of participants still alive and without tumor progression at study completion
Outcome measures
| Measure |
Series 1: Stereotactic Radiosurgery
n=4 Participants
Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 2: Stereotactic Radiosurgery
n=6 Participants
Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 1/Dose Level 3: Stereotactic Radiosurgery
n=3 Participants
Dose Level 3: Radiation will be delivered in 4 fractions:
10 Gy x 4 fractions: Total of 40 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 1/Dose Level 4: Stereotactic Radiosurgery
n=6 Participants
Dose Level 4: Radiation will be delivered in 4 fractions:
12 Gy x 4 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 1: Stereotactic Radiosurgery
n=4 Participants
Dose Level I: Radiation will be delivered in 3 fractions:
16 Gy X 3 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 2: Stereotactic Radiosurgery
n=4 Participants
Dose Level 2: Radiation will be delivered in 3 fractions:
18 Gy x 3 fractions: Total of 54 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 3: Stereotactic Radiosurgery
n=3 Participants
Dose Level 3: Radiation will be delivered in 3 fractions:
20 Gy x 3 fractions: Total of 60 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival
|
75 percentage of participants
|
100 percentage of participants
|
33 percentage of participants
|
66 percentage of participants
|
33 percentage of participants
|
100 percentage of participants
|
66 percentage of participants
|
SECONDARY outcome
Timeframe: at 36 months from start of therapyPopulation: All participants who received treatment.
Radiographic efficacy as measured as measured by freedom from local progression (percent of participants without local progression or local recurrence after study completion)
Outcome measures
| Measure |
Series 1: Stereotactic Radiosurgery
n=4 Participants
Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 2: Stereotactic Radiosurgery
n=6 Participants
Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 1/Dose Level 3: Stereotactic Radiosurgery
n=3 Participants
Dose Level 3: Radiation will be delivered in 4 fractions:
10 Gy x 4 fractions: Total of 40 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 1/Dose Level 4: Stereotactic Radiosurgery
n=6 Participants
Dose Level 4: Radiation will be delivered in 4 fractions:
12 Gy x 4 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 1: Stereotactic Radiosurgery
n=4 Participants
Dose Level I: Radiation will be delivered in 3 fractions:
16 Gy X 3 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 2: Stereotactic Radiosurgery
n=4 Participants
Dose Level 2: Radiation will be delivered in 3 fractions:
18 Gy x 3 fractions: Total of 54 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 3: Stereotactic Radiosurgery
n=3 Participants
Dose Level 3: Radiation will be delivered in 3 fractions:
20 Gy x 3 fractions: Total of 60 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
|---|---|---|---|---|---|---|---|
|
Freedom From Local Progression
|
100 percent
|
100 percent
|
100 percent
|
100 percent
|
100 percent
|
100 percent
|
66 percent
|
SECONDARY outcome
Timeframe: at 36 months from start of therapyPopulation: All participants who received treatment.
Radiographic efficacy as measured by distant recurrance (percent of participants without distant failure after study completion)
Outcome measures
| Measure |
Series 1: Stereotactic Radiosurgery
n=4 Participants
Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 2: Stereotactic Radiosurgery
n=6 Participants
Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 1/Dose Level 3: Stereotactic Radiosurgery
n=3 Participants
Dose Level 3: Radiation will be delivered in 4 fractions:
10 Gy x 4 fractions: Total of 40 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 1/Dose Level 4: Stereotactic Radiosurgery
n=6 Participants
Dose Level 4: Radiation will be delivered in 4 fractions:
12 Gy x 4 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 1: Stereotactic Radiosurgery
n=4 Participants
Dose Level I: Radiation will be delivered in 3 fractions:
16 Gy X 3 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 2: Stereotactic Radiosurgery
n=4 Participants
Dose Level 2: Radiation will be delivered in 3 fractions:
18 Gy x 3 fractions: Total of 54 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
Series 2/Dose Level 3: Stereotactic Radiosurgery
n=3 Participants
Dose Level 3: Radiation will be delivered in 3 fractions:
20 Gy x 3 fractions: Total of 60 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b
|
|---|---|---|---|---|---|---|---|
|
Freedom to Distant Recurrence
|
100 percent
|
100 percent
|
100 percent
|
100 percent
|
75 percent
|
100 percent
|
100 percent
|
Adverse Events
Series 1/Dose Level 1: Stereotactic Radiosurgery
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Series 1/Dose Level 2: Stereotactic Radiosurgery
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Series 1/Dose Level 3: Stereotactic Radiosurgery
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Series 1/Dose Level 4: Stereotactic Radiosurgery
Serious events: 3 serious events
Other events: 1 other events
Deaths: 2 deaths
Series 2/Dose Level 1: Stereotactic Radiosurgery
Serious events: 3 serious events
Other events: 1 other events
Deaths: 1 deaths
Series 2/Dose Level 2: Stereotactic Radiosurgery
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Series 2/Dose Level 3: Stereotactic Radiosurgery
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Series 1/Dose Level 1: Stereotactic Radiosurgery
n=4 participants at risk
Dose Level I: Radiation will be delivered in 4 fractions:
6 Gy x 4 fractions: Total of 24 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 1/Dose Level 2: Stereotactic Radiosurgery
n=6 participants at risk
Dose Level 2: Radiation will be delivered in 4 fractions:
8 Gy x 4 fractions: Total of 32 Gy
|
Series 1/Dose Level 3: Stereotactic Radiosurgery
n=3 participants at risk
Dose Level 3: Radiation will be delivered in 4 fractions:
10 Gy x 4 fractions: Total of 40 Gy
|
Series 1/Dose Level 4: Stereotactic Radiosurgery
n=6 participants at risk
Dose Level 4: Radiation will be delivered in 4 fractions:
12 Gy x 4 fractions: Total of 48 Gy
|
Series 2/Dose Level 1: Stereotactic Radiosurgery
n=4 participants at risk
Dose Level I: Radiation will be delivered in 3 fractions: 16 Gy X 3 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 2/Dose Level 2: Stereotactic Radiosurgery
n=4 participants at risk
Dose Level 2: Radiation will be delivered in 3 fractions: 18 Gy X 3 fractions: Total of 54 Gy
|
Series 2/Dose Level 3: Stereotactic Radiosurgery
n=3 participants at risk
Dose Level 3: Radiation will be delivered in 3 fractions: 20 Gy X 3 fractions: Total of 6 Gy
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Cardiac disorders
junctional rhythm
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
General disorders
Death not associated with CTCAE term - Multi-organ failure
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Gastrointestinal disorders
Obstruction, GI - Small bowel NOS
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Gastrointestinal disorders
Necrosis, GI - Colon/cecum/appendix
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Gastrointestinal disorders
Ulcer, GI - Duodenum
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
16.7%
1/6 • Number of events 3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Cardiac disorders
Pain - Cardiac/heart
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
General disorders
Pain - Chest wall
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Injury, poisoning and procedural complications
Pain-Head injury, head pain due to a fall.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Renal and urinary disorders
Renal/Genitourinary Urosepsis
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Nervous system disorders
Stroke
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
Other adverse events
| Measure |
Series 1/Dose Level 1: Stereotactic Radiosurgery
n=4 participants at risk
Dose Level I: Radiation will be delivered in 4 fractions:
6 Gy x 4 fractions: Total of 24 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 1/Dose Level 2: Stereotactic Radiosurgery
n=6 participants at risk
Dose Level 2: Radiation will be delivered in 4 fractions:
8 Gy x 4 fractions: Total of 32 Gy
|
Series 1/Dose Level 3: Stereotactic Radiosurgery
n=3 participants at risk
Dose Level 3: Radiation will be delivered in 4 fractions:
10 Gy x 4 fractions: Total of 40 Gy
|
Series 1/Dose Level 4: Stereotactic Radiosurgery
n=6 participants at risk
Dose Level 4: Radiation will be delivered in 4 fractions:
12 Gy x 4 fractions: Total of 48 Gy
|
Series 2/Dose Level 1: Stereotactic Radiosurgery
n=4 participants at risk
Dose Level I: Radiation will be delivered in 3 fractions: 16 Gy X 3 fractions: Total of 48 Gy
Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
Series 2/Dose Level 2: Stereotactic Radiosurgery
n=4 participants at risk
Dose Level 2: Radiation will be delivered in 3 fractions: 18 Gy X 3 fractions: Total of 54 Gy
|
Series 2/Dose Level 3: Stereotactic Radiosurgery
n=3 participants at risk
Dose Level 3: Radiation will be delivered in 3 fractions: 20 Gy X 3 fractions: Total of 6 Gy
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-upper
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Nervous system disorders
Pain - Head/headache
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Renal and urinary disorders
Incontinence, urinary
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Injury, poisoning and procedural complications
Intra-operative injury - NERVES: Peripheral sensory NOS
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Skin and subcutaneous tissue disorders
SKIN OTHER: RT LEG ECZEMA
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
66.7%
2/3 • Number of events 3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
General disorders
Rigors/chills
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
General disorders
Weight loss
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
50.0%
2/4 • Number of events 3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Gastrointestinal disorders
DIVERTICULITIS
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 5 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/6 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/4 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
0.00%
0/3 • Adverse events were collected over a ten year time period from study activation to study completion. AEs were collected over a 3 year time period for each participant while on study.
|
Additional Information
Mitchell Machtay MD
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Phone: 216-844-2530
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place