Anti-MART-1 F5 Cells Plus ALVAC MART-1 Vaccine to Treat Advanced Melanoma

This study has been terminated.
(The study was terminated due to low accrual.)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00612222
First received: February 8, 2008
Last updated: October 18, 2012
Last verified: October 2012
Results First Received: March 13, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Metastatic Melanoma
Skin Cancer
Interventions: Biological: autologous anti-MART-1 F5 T-cell receptor gene-engineered peripheral blood lymphocytes
Biological: ALVAC MART-1 Vaccine
Biological: aldesleukin
Drug: cyclophosphamide
Drug: fludarabine phosphate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Four participants were enrolled in 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
  Description
ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2

ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.

Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days.


Participant Flow:   Overall Study
    ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     0  



  Baseline Characteristics
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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
  Description
ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2

ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.

Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days.


Baseline Measures
    ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  43.8  ± 9.9  
Gender  
[units: participants]
 
Female     4  
Male     0  
Ethnicity (NIH/OMB)  
[units: Participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     4  
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     4  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures
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1.  Primary:   Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)   [ Time Frame: 4-6 weeks after treatment and then monthly for approximately 3 to 4 months or until off study criteria are met ]

2.  Secondary:   Number of Participants With in Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells   [ Time Frame: 1 month ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 15 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Early termination leading to small numbers of subjects analyzed.


  More Information
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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 A. Rosenberg, M.D.
Organization: National Cancer Institute (NCI), National Institutes of Health (NIH)
phone: 301-496-4164
e-mail: sar@mail.nih.gov


Publications:

Responsible Party: Steven A. Rosenberg, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00612222     History of Changes
Other Study ID Numbers: 080056, 08-C-0056
Study First Received: February 8, 2008
Results First Received: March 13, 2012
Last Updated: October 18, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration