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. 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
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One participant was enrolled to this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Metastatic Melanoma Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.

Participant Flow:   Overall Study
    Metastatic Melanoma

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Metastatic Melanoma Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.

Baseline Measures
   Metastatic Melanoma 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   1 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
[Units: Participants]
Female   0 
Male   1 
Ethnicity (NIH/OMB) 
[Units: Participants]
Hispanic or Latino   0 
Not Hispanic or Latino   1 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   1 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
United States   1 

  Outcome Measures

1.  Primary:   Number of Participants With an Objective Clinical Tumor Regression Response According to RECIST Criteria   [ Time Frame: 44 days ]

2.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 44 days ]

3.  Secondary:   Number of Participiants With In-vivo Survival of Infused Cells   [ Time Frame: 44 days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

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:  
Name/Title: Steven Rosenberg
Organization: National Cancer Institute, National Institutes of Health
phone: 301-496-4164


Responsible Party: Steven A. Rosenberg, M.D./National Cancer Institute, National Institutes of Health Identifier: NCT00924001     History of Changes
Obsolete Identifiers: NCT00537069
Other Study ID Numbers: 070210
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