Trial Outcomes & Findings for 153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer (NCT NCT00450619)
NCT ID: NCT00450619
Last Updated: 2017-01-04
Results Overview
Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Stable disease is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Partial response (PR) is at least a 30% increase in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions on computed tomography (CT) or two or more lesions on bone scan.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
4.7 months
Results posted on
2017-01-04
Participant Flow
Participant milestones
| Measure |
Arm A- EDTMP Alone
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153Sm-EDTMP With Vaccine
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Arm A- EDTMP Alone
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153Sm-EDTMP With Vaccine
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Overall Study
refused treatment after randomization
|
2
|
0
|
|
Overall Study
did not progress; refused further trmt
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A -EDTMP Alone
n=22 Participants
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153SmEDTMP With Vaccine
n=22 Participants
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
Total
n=44 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
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Continuous
|
64.73 years
STANDARD_DEVIATION 7.91 • n=5 Participants
|
69.65 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
67.18 years
STANDARD_DEVIATION 8.49 • n=5 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gender
Male
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Subjects requiring narcotic pain control
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Gleason Score
|
8 Scores on a scale
n=5 Participants
|
7.5 Scores on a scale
n=7 Participants
|
7.75 Scores on a scale
n=5 Participants
|
|
Prostate-Specific Antigen on Study
|
259.1 ng/mL of blood
n=5 Participants
|
313.5 ng/mL of blood
n=7 Participants
|
286.3 ng/mL of blood
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
|
1 Scores on a scale
n=5 Participants
|
1 Scores on a scale
n=7 Participants
|
1 Scores on a scale
n=5 Participants
|
|
Median Days since Prior Chemotherapy
|
57.5 Days
n=5 Participants
|
86.5 Days
n=7 Participants
|
72 Days
n=5 Participants
|
|
Lactate Dehydrogenase (serum)
|
254.5 U/L
n=5 Participants
|
200 U/L
n=7 Participants
|
227.25 U/L
n=5 Participants
|
|
Hemoglobin
|
11.2 g/dl
n=5 Participants
|
11.1 g/dl
n=7 Participants
|
11.15 g/dl
n=5 Participants
|
|
Alkaline Phosphatase
|
177 U/L
n=5 Participants
|
121.5 U/L
n=7 Participants
|
149.25 U/L
n=5 Participants
|
PRIMARY outcome
Timeframe: 4.7 monthsResponse is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Stable disease is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Partial response (PR) is at least a 30% increase in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions on computed tomography (CT) or two or more lesions on bone scan.
Outcome measures
| Measure |
Arm A - EDTMP Alone
n=18 Participants
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153Sm-EDTMP With Vaccine
n=21 Participants
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Number of Patients With Stable Disease at 4 Months.
|
2 participants
|
5 participants
|
PRIMARY outcome
Timeframe: 4 monthsPFS is defined as the time to progress or die after the start of the therapy.
Outcome measures
| Measure |
Arm A - EDTMP Alone
n=18 Participants
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153Sm-EDTMP With Vaccine
n=21 Participants
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
1.7 months
Interval 1.3 to 2.3
|
3.7 months
Interval 2.4 to 4.7
|
SECONDARY outcome
Timeframe: 5 years, 5 monthsHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Arm A - EDTMP Alone
n=21 Participants
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153Sm-EDTMP With Vaccine
n=22 Participants
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Toxicity
|
19 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPSA is defined by the PSA Working Group criteria. A minimum PSA decline of at least 50% must be confirmed by a second PSA value 4 or more weeks later.
Outcome measures
| Measure |
Arm A - EDTMP Alone
n=18 Participants
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153Sm-EDTMP With Vaccine
n=21 Participants
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Number of Participants With Prostate-Specific Antigen (PSA) ≥ 30%
|
0 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 4 monthsPSA is defined by the PSA Working Group criteria. A minimum PSA decline of at least 50% must be confirmed by a second PSA value 4 or more weeks later.
Outcome measures
| Measure |
Arm A - EDTMP Alone
n=18 Participants
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153Sm-EDTMP With Vaccine
n=21 Participants
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Number of Participants With Prostate-Specific Antigen (PSA) ≥50%
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: From date of randomization until death or last follow up, whichever comes first, assessed up to 14 months.Time from treatment start date until date of death or date last known alive.
Outcome measures
| Measure |
Arm A - EDTMP Alone
n=18 Participants
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153Sm-EDTMP With Vaccine
n=21 Participants
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Overall Survival
|
8.1 Months
Interval 3.5 to 13.3
|
9.2 Months
Interval 5.0 to 12.6
|
SECONDARY outcome
Timeframe: Approximately 60 daysPopulation: (a)Cytokine or CD107a in CD4 or CD8. \*Pts displayed pre-existing PSA-specific T-cell responses. Numbers 274, 630, and 1427 are those positive post- vs. pre-vaccination. Absolute # CD4 or CD8 producing cytokine/CD107a+/1x10(6) cells plated at start of in vitro stimulation.
PSA T-cell responses were measured by fluorescence activated cell sorting (FACS)-based assay for T-cells expressing type I cytokines interferon (IFN-ϓ), interleukin 2 (IL2), tumor necrosis factor alpha (TNF-a) and/or lysosome-associated membrane protein (CD107a).
Outcome measures
| Measure |
Arm A - EDTMP Alone
n=8 Participants
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153Sm-EDTMP With Vaccine
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 13* (CD4) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 11 (CD4) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 11 (CD4) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 11(CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 11 (CD4) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 11 (CD8) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 11 (CD8) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 11 (CD8) IL2
|
56 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 11 (CD8) TNF
|
186 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 13* (CD4) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 13* (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 13* (CD4) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 13* (CD8) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 13* (CD8) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 13* (CD8) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 13* (CD8) TNF
|
3 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 20* (CD4) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 20* (CD4) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 20* (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 20* (CD4) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 20* (CD8) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 20* (CD8) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 20* (CD8) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 20* (CD8) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 22 (CD4) CD107a
|
154 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 22 (CD4) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 22 (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 22 (CD4) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 22 (CD8) CD107a
|
1427 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 22 (CD8) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 22 (CD8) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 22 (CD8) TNF
|
274 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 25 (CD4) CD107a
|
146 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 25 (CD4) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 25 (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 25 (CD4) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 25 (CD8) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 25 (CD8) IFN-ϓ
|
248 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 25 (CD8) IL2
|
30 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 25 (CD8) TNF
|
630 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 3 (CD4) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 3 (CD4) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 3 (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 3 (CD4) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 3 (CD8) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 3 (CD8) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 3 (CD8) IL2
|
14 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 3 (CD8) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 5 (CD4) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 5 (CD4) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 5 (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 5 (CD4) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 5 (CD8) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 5 (CD8) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 5 (CD8) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 5 (CD8)TNF
|
25 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 10 (CD4) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 10 (CD4) IFN-ϓ
|
6 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 10 (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 10 (CD4) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 10 (CD8) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 10 (CD8) IFN-ϓ
|
21 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 10 (CD8) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 10 (CD8) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
SECONDARY outcome
Timeframe: Approximately 60 daysPopulation: (a)Cytokine or CD107a in CD4 or CD8. \*Pts displayed pre-existing PSA-specific T-cell responses. Numbers 786, 374, 345, 402, 821, 815, 5269, 453, 633, 1242 \& 0 for PT 2 CD4/CD8 IL2 \& 0 for PT 16 TNF are those positive post- vs. pre-vaccination. Absolute # CD4 or CD8 producing cytokine/CD107a+/1x10(6) cells plated at start of in vitro stimulation.
PSA T-cell responses were measured by fluorescence activated cell sorting (FACS)-based assay for T-cells expressing type I cytokines interferon (IFN-ϓ), interleukin 2 (IL2), tumor necrosis factor alpha (TNF-a) and/or lysosome-associated membrane protein (CD107a).
Outcome measures
| Measure |
Arm A - EDTMP Alone
n=10 Participants
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153Sm-EDTMP With Vaccine
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 2 (CD8) TNF
|
323 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 8 (CD4) CD107a
|
58 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 8 (CD4) IFN-ϓ
|
345 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 8 (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 8 (CD4) TNF
|
245 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 12 (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 12 (CD4) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 21 (CD8) IFN-ϓ
|
214 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 21 (CD8) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 21 (CD8) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 24* (CD8) IL2
|
8 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 24* (CD8) TNF
|
179 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 27* (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 27* (CD4) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 27* (CD8) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 2 (CD4) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 2 (CD4) IFN-ϓ
|
786 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 2 (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 2 (CD4) TNF
|
374 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 2 (CD8) CD107a
|
5269 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 2 (CD8) IFN-ϓ
|
453 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 2 (CD8) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 8 (CD8) CD107a
|
633 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 8 (CD8) IFN-ϓ
|
136 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 8 (CD8) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 8 (CD8) TNF
|
35 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 12 (CD4) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 12 (CD4) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 12 (CD8) CD107a
|
58 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 12 (CD8) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 12 (CD8) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 12 (CD8) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 18 (CD4) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 18 (CD4) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 18 (CD4) IL2
|
75 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 18 (CD4) TNF
|
402 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 18 (CD8) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 18 (CD8) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 18 (CD8) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 18 (CD8) TNF
|
35 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 21 (CD4) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 21 (CD4) IFN-ϓ
|
45 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 21 (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 21 (CD4) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 11 (CD8) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 24* (CD4) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 24* (CD4) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 24* (CD4) IL2
|
149 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 24* (CD4) TNF
|
181 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 24* (CD8) CD107a
|
1242 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 24* (CD8) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 14 (CD4) CD107a
|
821 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 14 (CD4) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 14 (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 14 (CD4) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 14 (CD8) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 14 (CD8) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 14 (CD8) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 14 (CD8) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 16 (CD4) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 16 (CD4) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 16 (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 16 (CD4) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 16 (CD8) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 16 (CD8) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 16 (CD8) IL2
|
9 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 16 (CD8) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 26 (CD4) CD107a
|
815 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 26 (CD4) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 26 (CD4) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 26 (CD4) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 26 (CD8) CD107a
|
149 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 26 (CD8) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 26 (CD8) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 26 (CD8) TNF
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 27* (CD4) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 27* (CD4) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 27* (CD8) CD107a
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 27* (CD8) IFN-ϓ
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
|
Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment
PT 27* (CD8) IL2
|
0 Absolute # CD4 or CD8 producing cytokine
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Not all participants was measureable by RECIST.
Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% increase in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Arm A - EDTMP Alone
n=18 Participants
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153Sm-EDTMP With Vaccine
n=21 Participants
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Objective Response (Complete Response + Partial Response)
Complete Response
|
0 participants
|
0 participants
|
|
Objective Response (Complete Response + Partial Response)
Partial Response
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselineSubjective report of participant pain at baseline.This data reflects National Cancer Institute (NCI) patients only. This data was not systematically captured, so these results are based on subjective patient reports of improvement in pain on a scale of 1-10 post quadramet (samarium) as documented in the progress notes. 1-2 equals mild pain and 9-10 equals worst possible pain.
Outcome measures
| Measure |
Arm A - EDTMP Alone
n=14 Participants
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153Sm-EDTMP With Vaccine
n=13 Participants
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Palliation: Pain at Baseline
|
10 participants
|
8 participants
|
SECONDARY outcome
Timeframe: post quadramet (samarium)Subjective report of participant pain at baseline. This data reflects National Cancer Institute (NCI) patients only. This data was not systematically captured, so these results are based on subjective patient reports of improvement in pain on a scale of 1-10 post quadramet (samarium) as documented in the progress notes. 1-2 equals mild pain and 9-10 equals worst possible pain.
Outcome measures
| Measure |
Arm A - EDTMP Alone
n=10 Participants
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153Sm-EDTMP With Vaccine
n=8 Participants
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Palliation: Improvement in Baseline Pain
|
6 participants
|
5 participants
|
Adverse Events
Arm A -EDTMP Alone
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Arm B - 153SmEDTMP With Vaccine
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A -EDTMP Alone
n=21 participants at risk
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153SmEDTMP With Vaccine
n=22 participants at risk
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.8%
1/21 • Number of events 3
|
0.00%
0/22
|
|
General disorders
Death NOS
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Fatigue
|
4.8%
1/21 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Number of events 3
|
0.00%
0/22
|
|
General disorders
Pain
|
4.8%
1/21 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
|
Investigations
Platelet count decreased
|
4.8%
1/21 • Number of events 1
|
4.5%
1/22 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 3
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Infections and infestations, Other, specify
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
Other adverse events
| Measure |
Arm A -EDTMP Alone
n=21 participants at risk
Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - 153SmEDTMP With Vaccine
n=22 participants at risk
Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Bruising
|
9.5%
2/21 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
|
Investigations
CPK increased
|
9.5%
2/21 • Number of events 2
|
0.00%
0/22
|
|
Cardiac disorders
Cardiac disorders - Other, (sinus tachycardia)
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.8%
1/21 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
23.8%
5/21 • Number of events 6
|
22.7%
5/22 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Creatinine increased
|
9.5%
2/21 • Number of events 2
|
9.1%
2/22 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
3/21 • Number of events 3
|
0.00%
0/22
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21 • Number of events 4
|
18.2%
4/22 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.5%
2/21 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
|
General disorders
Edema: limbs
|
9.5%
2/21 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
|
General disorders
Fatigue
|
47.6%
10/21 • Number of events 13
|
54.5%
12/22 • Number of events 24
|
|
General disorders
Fever
|
14.3%
3/21 • Number of events 3
|
13.6%
3/22 • Number of events 7
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
1/21 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Gastroparesis
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.8%
1/21 • Number of events 3
|
0.00%
0/22
|
|
Vascular disorders
Hematoma
|
9.5%
2/21 • Number of events 2
|
0.00%
0/22
|
|
Renal and urinary disorders
Hematuria
|
9.5%
2/21 • Number of events 3
|
9.1%
2/22 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemolysis
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
Vascular disorders
Hot flashes
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.5%
2/21 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
3/21 • Number of events 3
|
36.4%
8/22 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
19.0%
4/21 • Number of events 6
|
18.2%
4/22 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
14.3%
3/21 • Number of events 4
|
27.3%
6/22 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
38.1%
8/21 • Number of events 12
|
27.3%
6/22 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
3/21 • Number of events 7
|
22.7%
5/22 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
1/21 • Number of events 1
|
9.1%
2/22 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.5%
2/21 • Number of events 2
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
6/21 • Number of events 7
|
4.5%
1/22 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.8%
1/21 • Number of events 1
|
9.1%
2/22 • Number of events 4
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • Number of events 3
|
4.5%
1/22 • Number of events 1
|
|
Investigations
INR increased
|
4.8%
1/21 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Investigations-Other, specify
|
9.5%
2/21 • Number of events 2
|
9.1%
2/22 • Number of events 3
|
|
Investigations
Lymphocyte count decreased
|
52.4%
11/21 • Number of events 19
|
50.0%
11/22 • Number of events 21
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
9.5%
2/21 • Number of events 6
|
9.1%
2/22 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder-Other, specify
|
4.8%
1/21 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
38.1%
8/21 • Number of events 11
|
31.8%
7/22 • Number of events 8
|
|
Nervous system disorders
Nervous system disorders - Other, (sensory neuropathy)
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
Investigations
Neutrophil count decreased
|
38.1%
8/21 • Number of events 15
|
72.7%
16/22 • Number of events 43
|
|
Gastrointestinal disorders
Oral hemorrhage
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Pain
|
28.6%
6/21 • Number of events 6
|
40.9%
9/22 • Number of events 13
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.8%
1/21 • Number of events 1
|
13.6%
3/22 • Number of events 3
|
|
Investigations
Platelet count decreased
|
66.7%
14/21 • Number of events 29
|
86.4%
19/22 • Number of events 56
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
Renal and urinary disorders
Proteinuria
|
9.5%
2/21 • Number of events 2
|
36.4%
8/22 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Purpura
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
Cardiac disorders
Sinus tachycardia
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
Vascular disorders
Thromboembolic event
|
4.8%
1/21 • Number of events 5
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
4.8%
1/21 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract infection
|
4.8%
1/21 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract obstruction
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
Gastrointestinal disorders
Vomiting
|
23.8%
5/21 • Number of events 6
|
18.2%
4/22 • Number of events 4
|
|
Investigations
Weight loss
|
23.8%
5/21 • Number of events 6
|
22.7%
5/22 • Number of events 5
|
|
Investigations
White blood cell decreased
|
66.7%
14/21 • Number of events 29
|
77.3%
17/22 • Number of events 49
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21
|
9.1%
2/22 • Number of events 2
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Eye disorders
Blurred vision
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Chills
|
0.00%
0/21
|
18.2%
4/22 • Number of events 5
|
|
Psychiatric disorders
Confusion
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Edema face
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/21
|
18.2%
4/22 • Number of events 4
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Flu like symptoms
|
0.00%
0/21
|
31.8%
7/22 • Number of events 9
|
|
General disorders
Gait disturbance
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/21
|
18.2%
4/22 • Number of events 6
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/21
|
13.6%
3/22 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/21
|
9.1%
2/22 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Tooth infection
|
0.00%
0/21
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/21
|
9.1%
2/22 • Number of events 3
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/21
|
4.5%
1/22 • Number of events 2
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/21
|
9.1%
2/22 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/21
|
9.1%
2/22 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21
|
22.7%
5/22 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
sinus disorder
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/21
|
4.5%
1/22 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/21
|
13.6%
3/22 • Number of events 4
|
|
Infections and infestations
Infections and infestations, Other, specify
|
0.00%
0/21
|
4.5%
1/22 • Number of events 2
|
|
General disorders
Injection site reaction
|
0.00%
0/21
|
50.0%
11/22 • Number of events 34
|
|
Investigations
Alanine aminotransferase increased
|
19.0%
4/21 • Number of events 4
|
0.00%
0/22
|
|
Investigations
Alkaline phosphatase increased
|
42.9%
9/21 • Number of events 13
|
45.5%
10/22 • Number of events 15
|
|
Blood and lymphatic system disorders
Anemia
|
57.1%
12/21 • Number of events 28
|
81.8%
18/22 • Number of events 45
|
|
Metabolism and nutrition disorders
Anorexia
|
38.1%
8/21 • Number of events 8
|
36.4%
8/22 • Number of events 11
|
|
Psychiatric disorders
Anxiety
|
4.8%
1/21 • Number of events 1
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • Number of events 3
|
13.6%
3/22 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
6/21 • Number of events 8
|
27.3%
6/22 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
3/21 • Number of events 3
|
18.2%
4/22 • Number of events 5
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
4.8%
1/21 • Number of events 2
|
0.00%
0/22
|
|
Investigations
Blood bilirubin increased
|
14.3%
3/21 • Number of events 3
|
9.1%
2/22 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
19.0%
4/21 • Number of events 4
|
27.3%
6/22 • Number of events 12
|
Additional Information
Dr. James Gulley, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-435-2956
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place