Trial Outcomes & Findings for Chemotherapy Followed by Infusion of DMF5 Cells to Treat Metastatic Melanoma (NCT NCT00924001)
NCT ID: NCT00924001
Last Updated: 2012-10-25
Results Overview
Response is determined 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% decrease in the target lesions, progression (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
TERMINATED
PHASE1/PHASE2
1 participants
44 days
2012-10-25
Participant Flow
One participant was enrolled to this study.
Participant milestones
| Measure |
Metastatic Melanoma
Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy Followed by Infusion of DMF5 Cells to Treat Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Metastatic Melanoma
n=1 Participants
Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
32.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 44 daysResponse is determined 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% decrease in the target lesions, progression (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Metastatic Melanoma
n=1 Participants
Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
|
|---|---|
|
Number of Participants With an Objective Clinical Tumor Regression Response According to RECIST Criteria
|
0 Participants
|
PRIMARY outcome
Timeframe: 44 daysHere are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Metastatic Melanoma
n=1 Participants
Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
|
|---|---|
|
Number of Participants With Adverse Events
|
1 Participants
|
SECONDARY outcome
Timeframe: 44 daysIn-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS).
Outcome measures
| Measure |
Metastatic Melanoma
n=1 Participants
Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
|
|---|---|
|
Number of Participiants With In-vivo Survival of Infused Cells
|
1 Participants
|
Adverse Events
Metastatic Melanoma
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metastatic Melanoma
n=1 participants at risk
Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
100.0%
1/1 • Number of events 1 • 44 days
|
|
Blood and lymphatic system disorders
Leukocyte count decreased
|
100.0%
1/1 • Number of events 1 • 44 days
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
100.0%
1/1 • Number of events 1 • 44 days
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
100.0%
1/1 • Number of events 1 • 44 days
|
|
Blood and lymphatic system disorders
Platelet cout decreased
|
100.0%
1/1 • Number of events 1 • 44 days
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
100.0%
1/1 • Number of events 1 • 44 days
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 1 • 44 days
|
|
Gastrointestinal disorders
Dyspepsia
|
100.0%
1/1 • Number of events 1 • 44 days
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 2 • 44 days
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Number of events 1 • 44 days
|
|
Infections and infestations
Sepsis
|
100.0%
1/1 • Number of events 1 • 44 days
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Number of events 1 • 44 days
|
|
General disorders
Chest pain
|
100.0%
1/1 • Number of events 1 • 44 days
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 2 • 44 days
|
|
Gastrointestinal disorders
Oral pain
|
100.0%
1/1 • Number of events 1 • 44 days
|
Additional Information
Steven Rosenberg
National Cancer Institute, National Institutes of Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place