Trial Outcomes & Findings for Radiation, Chemotherapy, Vaccine and Anti-MART-1 and Anti-gp100 Cells for Patients With Metastatic Melanoma (NCT NCT00923195)
NCT ID: NCT00923195
Last Updated: 2015-10-28
Results Overview
Complete response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is a disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression 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. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Every 4-6 weeks after initial treatment regimen. If the patient has stable disease or tumor shrinkage, complete evaluations will be repeated every 1-3 months.
Results posted on
2015-10-28
Participant Flow
Participant milestones
| Measure |
TBI 600cGy + PBL + HD IL-2+gp100:154-162
Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
|
TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)
Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
TBI 600cGy + PBL + HD IL-2+gp100:154-162
Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
|
TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)
Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Radiation, Chemotherapy, Vaccine and Anti-MART-1 and Anti-gp100 Cells for Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
TBI 600cGy + PBL + HD IL-2+gp100:154-162
n=2 Participants
Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
|
TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)
n=2 Participants
Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
|
Total
n=4 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
48.0 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 4-6 weeks after initial treatment regimen. If the patient has stable disease or tumor shrinkage, complete evaluations will be repeated every 1-3 months.Complete response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is a disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression 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. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.
Outcome measures
| Measure |
TBI 600cGy + PBL + HD IL-2+gp100:154-162
n=2 Participants
Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
|
TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)
n=2 Participants
Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
|
|---|---|---|
|
Complete Response Rates for Patients With Metastatic Melanoma
Complete Response
|
0 Participants
|
0 Participants
|
|
Complete Response Rates for Patients With Metastatic Melanoma
Partial Response
|
0 Participants
|
0 Participants
|
|
Complete Response Rates for Patients With Metastatic Melanoma
Progressive Disease
|
2 Participants
|
2 Participants
|
|
Complete Response Rates for Patients With Metastatic Melanoma
Stable Disease
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 32 monthsHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
TBI 600cGy + PBL + HD IL-2+gp100:154-162
n=2 Participants
Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
|
TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)
n=2 Participants
Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
|
|---|---|---|
|
Toxicity Profile
|
2 Participants
|
2 Participants
|
Adverse Events
TBI 600cGy + PBL + HD IL-2+gp100:154-162
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TBI 600cGy + PBL + HD IL-2+gp100:154-162
n=2 participants at risk
Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
|
TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)
n=2 participants at risk
Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
|
|---|---|---|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
50.0%
1/2 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Nervous system disorders
Seizure
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
Other adverse events
| Measure |
TBI 600cGy + PBL + HD IL-2+gp100:154-162
n=2 participants at risk
Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
|
TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)
n=2 participants at risk
Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
|
|---|---|---|
|
Ear and labyrinth disorders
Hearing test abnormal
|
100.0%
2/2 • Number of events 3
|
100.0%
2/2 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
100.0%
2/2 • Number of events 2
|
100.0%
2/2 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocyte count decreased
|
100.0%
2/2 • Number of events 2
|
100.0%
2/2 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
100.0%
2/2 • Number of events 3
|
100.0%
2/2 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
100.0%
2/2 • Number of events 2
|
100.0%
2/2 • Number of events 4
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
100.0%
2/2 • Number of events 2
|
100.0%
2/2 • Number of events 2
|
|
Cardiac disorders
Hypotension
|
50.0%
1/2 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
Activated partial thromboplastin time prolonged
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
100.0%
2/2 • Number of events 2
|
100.0%
2/2 • Number of events 2
|
|
Infections and infestations
Febrile Neutropenia
|
100.0%
2/2 • Number of events 2
|
100.0%
2/2 • Number of events 3
|
|
Infections and infestations
Sepsis
|
50.0%
1/2 • Number of events 1
|
50.0%
1/2 • Number of events 4
|
|
Infections and infestations
Wound infection
|
50.0%
1/2 • Number of events 6
|
0.00%
0/2
|
|
Infections and infestations
Upper respiratory infection
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Acidosis
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
100.0%
2/2 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Bilirubin increased
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Creatinine increased
|
100.0%
2/2 • Number of events 2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
50.0%
1/2 • Number of events 1
|
100.0%
2/2 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Confusion
|
100.0%
2/2 • Number of events 2
|
0.00%
0/2
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Eye disorders
Uveitis
|
50.0%
1/2 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Reproductive system and breast disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Renal and urinary disorders
Low urine output
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Renal and urinary disorders
Renal failure
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Cardiac disorders
Hypertension
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/2
|
50.0%
1/2 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Infections and infestations
Catheter-related infection
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2
|
50.0%
1/2 • Number of events 2
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
100.0%
2/2 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/2
|
100.0%
2/2 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Nervous system disorders
Psychosis
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
Additional Information
Dr. Steven Rosenberg
National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place