Prospective Randomized Comparative Study of Cell Transfer Therapy Using CD8+-Enriched Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen Compared to High-Dose Aldesleukin in M...

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01118091
First received: May 5, 2010
Last updated: May 29, 2013
Last verified: May 2013
Results First Received: November 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Skin Cancer
Melanoma
Metastatic Melanoma
Interventions: Biological: Aldesleukin
Biological: CD8 enriched Young TIL

  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
No text entered.

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
Arm 1 - Aldesleukin

Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.

Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.

Arm 2 - Adoptive Cell Therapy

Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.

CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin.


Participant Flow:   Overall Study
    Arm 1 - Aldesleukin     Arm 2 - Adoptive Cell Therapy  
STARTED     7 [1]   5  
COMPLETED     7 [2]   5  
NOT COMPLETED     0     0  
[1] 2pts were randomized to Arm 2, were not able to grow cell product, were treated with Arm 1 regimen.
[2] Continued from above: These 2 pts are only represented in Arm 1 (and not Arm 2).



  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
Arm 1 - Aldesleukin

Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.

Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.

Arm 2 - Adoptive Cell Therapy

Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.

CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin.

Total Total of all reporting groups

Baseline Measures
    Arm 1 - Aldesleukin     Arm 2 - Adoptive Cell Therapy     Total  
Number of Participants  
[units: participants]
  7     5     12  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     4     11  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  44.7  ± 8.2     53.6  ± 9.5     49.15  ± 8.85  
Gender  
[units: participants]
     
Female     2     2     4  
Male     5     3     8  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     7     5     12  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: 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     7     5     12  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     7     5     12  



  Outcome Measures
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1.  Primary:   Response Rate   [ Time Frame: 3 years ]

2.  Primary:   Progression Free Survival   [ Time Frame: 3 years ]

3.  Secondary:   Toxicity   [ Time Frame: 3 years ]


  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
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  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: Dr. Steven Rosenberg
Organization: National Cancer Institute, National Institutes of Health
phone: 301-496-4164
e-mail: sar@mail.nih.gov


Publications:

Responsible Party: Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01118091     History of Changes
Other Study ID Numbers: 100117, 10-C-0117
Study First Received: May 5, 2010
Results First Received: November 9, 2012
Last Updated: May 29, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration