Trial Outcomes & Findings for Chemotherapy Followed by gp100 Lymphocytes and Aldesleukin to Treat Melanoma (NCT NCT00665470)
NCT ID: NCT00665470
Last Updated: 2015-10-19
Results Overview
Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) 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 (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
30 months
Results posted on
2015-10-19
Participant Flow
All patients were enrolled into cohort I because all patients were able to receive high dose IL-2.
Participant milestones
| Measure |
Cohort I - High Dose Aldesleukin
Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
|
Cohort II - Low Dose Aldesleukin
Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
0
|
|
Overall Study
COMPLETED
|
10
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy Followed by gp100 Lymphocytes and Aldesleukin to Treat Melanoma
Baseline characteristics by cohort
| Measure |
Cohort I - High Dose Aldesleukin
n=10 Participants
Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
|
Cohort II - Low Dose Aldesleukin
Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 participants
n=5 Participants
|
—
|
9 participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Age, Continuous
|
54.36 years
STANDARD_DEVIATION 9.23 • n=5 Participants
|
—
|
54.36 years
STANDARD_DEVIATION 9.23 • n=5 Participants
|
|
Gender
Female
|
2 participants
n=5 Participants
|
—
|
2 participants
n=5 Participants
|
|
Gender
Male
|
8 participants
n=5 Participants
|
—
|
8 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
—
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
—
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
—
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 monthsResponse is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) 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 (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Outcome measures
| Measure |
Cohort I - High Dose Aldesleukin
n=10 Participants
Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
|
Cohort II - Low Dose Aldesleukin
Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
|
|---|---|---|
|
Response
Complete Response
|
0 Participants
|
—
|
|
Response
Partial Response
|
0 Participants
|
—
|
|
Response
Progression
|
8 Participants
|
—
|
|
Response
Stable Disease
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: 16 monthsHere is the number of participants with adverse events. For a detailed list of participants with adverse events, see the adverse event module.
Outcome measures
| Measure |
Cohort I - High Dose Aldesleukin
n=10 Participants
Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
|
Cohort II - Low Dose Aldesleukin
Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
|
|---|---|---|
|
Toxicity as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V3.0
|
10 Participants
|
—
|
Adverse Events
Cohort I - High Dose Aldesleukin
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort II - Low Dose Aldesleukin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort I - High Dose Aldesleukin
n=10 participants at risk
Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
|
Cohort II - Low Dose Aldesleukin
Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1
|
—
0/0
|
|
General disorders
Esophagitis
|
10.0%
1/10 • Number of events 1
|
—
0/0
|
|
Vascular disorders
Thromboembolic event
|
10.0%
1/10 • Number of events 1
|
—
0/0
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1
|
—
0/0
|
Other adverse events
| Measure |
Cohort I - High Dose Aldesleukin
n=10 participants at risk
Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
|
Cohort II - Low Dose Aldesleukin
Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
|
|---|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
30.0%
3/10 • Number of events 3
|
—
0/0
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
4/10 • Number of events 5
|
—
0/0
|
|
Nervous system disorders
Cognitive disturbance
|
10.0%
1/10 • Number of events 1
|
—
0/0
|
|
Nervous system disorders
Confusion
|
20.0%
2/10 • Number of events 2
|
—
0/0
|
|
Metabolism and nutrition disorders
Creatinine increased
|
10.0%
1/10 • Number of events 1
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
3/10 • Number of events 3
|
—
0/0
|
|
General disorders
Fatigue
|
50.0%
5/10 • Number of events 5
|
—
0/0
|
|
Infections and infestations
Febrile neutropenia
|
50.0%
5/10 • Number of events 6
|
—
0/0
|
|
General disorders
Fever
|
10.0%
1/10 • Number of events 1
|
—
0/0
|
|
Ear and labyrinth disorders
Hearing impaired
|
10.0%
1/10 • Number of events 1
|
—
0/0
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
10.0%
1/10 • Number of events 1
|
—
0/0
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
2/10 • Number of events 2
|
—
0/0
|
|
Cardiac disorders
Hypotension
|
10.0%
1/10 • Number of events 1
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Number of events 1
|
—
0/0
|
|
Infections and infestations
Infections and infestations - Other, infection: klebsiella pneumoniae
|
10.0%
1/10 • Number of events 1
|
—
0/0
|
|
Investigations
Lymphocyte count decreased
|
100.0%
10/10 • Number of events 12
|
—
0/0
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1
|
—
0/0
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
100.0%
10/10 • Number of events 11
|
—
0/0
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
100.0%
10/10 • Number of events 11
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Rash maculo-papular
|
60.0%
6/10 • Number of events 6
|
—
0/0
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
100.0%
10/10 • Number of events 11
|
—
0/0
|
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