Trial Outcomes & Findings for Gene-Modified Lymphocytes, High-Dose Aldesleukin, and Vaccine Therapy in Treating Patients With Progressive or Recurrent Metastatic Cancer (NCT NCT00704938)
NCT ID: NCT00704938
Last Updated: 2015-10-28
Results Overview
Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all lesions. Partial response is a 30% decrease in the sum of the longest diameter (LD) of target lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
5 months
Results posted on
2015-10-28
Participant Flow
Participant milestones
| Measure |
Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC
Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
|
Anti-p53 TCR PBL + DC + IL-2: Other Histology
Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gene-Modified Lymphocytes, High-Dose Aldesleukin, and Vaccine Therapy in Treating Patients With Progressive or Recurrent Metastatic Cancer
Baseline characteristics by cohort
| Measure |
Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC
n=2 Participants
Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
|
Anti-p53 TCR PBL + DC + IL-2: Other Histology
n=1 Participants
Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
|
Total
n=3 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
|
1 Participants
n=7 Participants
|
3 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
|
36.5 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
58.0 years
n=7 Participants
|
47.25 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 Participants
n=7 Participants
|
3 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
|
1 Participants
n=7 Participants
|
3 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
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 monthsClinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all lesions. Partial response is a 30% decrease in the sum of the longest diameter (LD) of target lesions.
Outcome measures
| Measure |
Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC
n=2 Participants
Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
|
Anti-p53 TCR PBL + DC + IL-2: Other Histology
n=1 Participants
Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
|
|---|---|---|
|
Clinical Response (Complete Response + Partial Response)
Complete Response
|
0 Participants
|
0 Participants
|
|
Clinical Response (Complete Response + Partial Response)
Partial Response
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 monthsHere is the number of participants with adverse events. For the detailed list of adverse events see the adverse events module.
Outcome measures
| Measure |
Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC
n=2 Participants
Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
|
Anti-p53 TCR PBL + DC + IL-2: Other Histology
n=1 Participants
Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
|
|---|---|---|
|
Number of Participants With Adverse Events
|
2 Participants
|
1 Participants
|
Adverse Events
Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Anti-p53 TCR PBL + DC + IL-2: Other Histology
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC
n=2 participants at risk
Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
|
Anti-p53 TCR PBL + DC + IL-2: Other Histology
n=1 participants at risk
Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
100.0%
2/2 • Number of events 3 • 5 months
|
100.0%
1/1 • Number of events 1 • 5 months
|
|
Blood and lymphatic system disorders
Leukocyte count decreased
|
100.0%
2/2 • Number of events 2 • 5 months
|
100.0%
1/1 • Number of events 1 • 5 months
|
|
Blood and lymphatic system disorders
lymphocyte count decreased
|
100.0%
2/2 • Number of events 2 • 5 months
|
100.0%
1/1 • Number of events 1 • 5 months
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
100.0%
2/2 • Number of events 2 • 5 months
|
100.0%
1/1 • Number of events 1 • 5 months
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
100.0%
2/2 • Number of events 2 • 5 months
|
100.0%
1/1 • Number of events 1 • 5 months
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
50.0%
1/2 • Number of events 1 • 5 months
|
0.00%
0/1 • 5 months
|
|
Nervous system disorders
Confusion
|
50.0%
1/2 • Number of events 1 • 5 months
|
0.00%
0/1 • 5 months
|
|
Nervous system disorders
Optic nerve disorder
|
50.0%
1/2 • Number of events 1 • 5 months
|
0.00%
0/1 • 5 months
|
|
Nervous system disorders
Pharyngolaryngeal pain
|
50.0%
1/2 • Number of events 1 • 5 months
|
0.00%
0/1 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
50.0%
1/2 • Number of events 1 • 5 months
|
0.00%
0/1 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Number of events 1 • 5 months
|
0.00%
0/1 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Number of events 1 • 5 months
|
100.0%
1/1 • Number of events 1 • 5 months
|
|
Renal and urinary disorders
Low urine output
|
50.0%
1/2 • Number of events 2 • 5 months
|
0.00%
0/1 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.00%
0/2 • 5 months
|
100.0%
1/1 • Number of events 1 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • 5 months
|
100.0%
1/1 • Number of events 1 • 5 months
|
Additional Information
Steven A. Rosenberg, M.D.
National Cancer Institute, National Institues of Health
Phone: 301-496-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place