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Chemotherapy Followed by Infusion of DMF5 Cells to Treat Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00924001
Recruitment Status : Terminated (study was stopped due to low accrual)
First Posted : June 18, 2009
Results First Posted : June 7, 2012
Last Update Posted : October 25, 2012
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Melanoma
Malignant Melanoma
Melanoma, Experimental
Interventions Drug: DMF5 Melanoma Reactive TIL
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Aldesleukin
Enrollment 1
Recruitment Details One participant was enrolled to this study.
Pre-assignment Details  
Arm/Group Title Metastatic Melanoma
Hide Arm/Group Description Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Metastatic Melanoma
Hide Arm/Group Description Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
32.0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Number of Participants With an Objective Clinical Tumor Regression Response According to RECIST Criteria
Hide Description 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.
Time Frame 44 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metastatic Melanoma
Hide Arm/Group Description:
Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Participants
0
2.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Time Frame 44 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metastatic Melanoma
Hide Arm/Group Description:
Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Participants
1
3.Secondary Outcome
Title Number of Participiants With In-vivo Survival of Infused Cells
Hide Description In-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).
Time Frame 44 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metastatic Melanoma
Hide Arm/Group Description:
Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Participants
1
Time Frame 44 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metastatic Melanoma
Hide Arm/Group Description Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
All-Cause Mortality
Metastatic Melanoma
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Metastatic Melanoma
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metastatic Melanoma
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  1/1 (100.00%)  1
Leukocyte count decreased  1  1/1 (100.00%)  1
Lymphocyte count decreased  1  1/1 (100.00%)  1
Neutrophil count decreased  1  1/1 (100.00%)  1
Platelet cout decreased  1  1/1 (100.00%)  1
Gastrointestinal disorders   
Diarrhea  1  1/1 (100.00%)  1
Dyspepsia  1  1/1 (100.00%)  1
Nausea  1  1/1 (100.00%)  2
Vomiting  1  1/1 (100.00%)  1
Oral pain  1  1/1 (100.00%)  1
General disorders   
Chest pain  1  1/1 (100.00%)  1
Infections and infestations   
Sepsis  1  1/1 (100.00%)  1
Nervous system disorders   
Dizziness  1  1/1 (100.00%)  1
Headache  1  1/1 (100.00%)  2
Skin and subcutaneous tissue disorders   
Rash desquamating  1  1/1 (100.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv3.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Rosenberg
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
EMail: sar@mail.nih.gov
Layout table for additonal information
Responsible Party: Steven A. Rosenberg, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00924001    
Obsolete Identifiers: NCT00537069
Other Study ID Numbers: 070210
07-C-0210
First Submitted: June 17, 2009
First Posted: June 18, 2009
Results First Submitted: December 22, 2011
Results First Posted: June 7, 2012
Last Update Posted: October 25, 2012