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Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00096382
First received: November 9, 2004
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
Results First Received: November 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma (Skin)
Interventions: Biological: aldesleukin
Biological: filgrastim
Biological: therapeutic tumor infiltrating lymphocytes
Drug: cyclophosphamide
Drug: fludarabine phosphate
Radiation: radiation therapy

  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
Of the 34 participants who were enrolled, 8 patients were not assigned to treatment since their TIL did not grow. Of the 26 assigned to treatment, 1 patient was not actually treated therefore only 25 patients were evaluable.

Reporting Groups
  Description
TBI 200cGy + TIL +HD IL-2, Prior IL-2

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
TBI 200cGy + TIL +HD IL-2, No Prior IL-2

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.

Participant Flow:   Overall Study
    TBI 200cGy + TIL +HD IL-2, Prior IL-2     TBI 200cGy + TIL +HD IL-2, No Prior IL-2  
STARTED     23     3  
COMPLETED     21     3  
NOT COMPLETED     2     0  
Not treated                 1                 0  
Death during treatment                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
TBI 200cGy + TIL +HD IL-2, Prior IL-2

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
TBI 200cGy + TIL +HD IL-2, No Prior IL-2

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
Total Total of all reporting groups

Baseline Measures
    TBI 200cGy + TIL +HD IL-2, Prior IL-2     TBI 200cGy + TIL +HD IL-2, No Prior IL-2     Total  
Number of Participants  
[units: participants]
 		  23     3     26  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     23     3     26  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  43.9  ± 9.6     48.3  ± 12.0     44.4  ± 9.7  
Gender  
[units: participants]
 		     
Female     8     0     8  
Male     15     3     18  
Ethnicity (NIH/OMB)  
[units: Participants]
 		     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     23     3     26  
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     23     3     26  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     23     3     26  



  Outcome Measures
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1.  Primary:   Clinical Tumor Regression   [ Time Frame: Every 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years. ]
  Show Outcome Measure 1

2.  Primary:   Safety   [ Time Frame: 4 years ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


Results Point of Contact:  
Name/Title: Steven A. Rosenberg, M.D.
Organization: National Cancer Institute, National Institutes of Health
phone: 301-496-4164
e-mail: sar@mail.nih.gov


No publications provided by National Institutes of Health Clinical Center (CC)

Publications automatically indexed to this study:


Responsible Party: Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00096382     History of Changes
Obsolete Identifiers: NCT00092248
Other Study ID Numbers: 040288, 04-C-0288, NCI-7025, NCI-PRMC-P6273, CDR0000393480
Study First Received: November 9, 2004
Results First Received: November 20, 2012
Last Updated: March 25, 2013
Health Authority: United States: Food and Drug Administration