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Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00085423
First received: June 10, 2004
Last updated: April 9, 2013
Last verified: April 2013
Results First Received: January 26, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma (Skin)
Interventions: Biological: aldesleukin
Biological: sargramostim
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
recruitment was open from February 2004 to December 2008.

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
Lymphodepleting Chemotherapy + High Dose Interleukin-2

Lymphodepleting chemotherapy + high dose interleukin-2:

Intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). Granulocyte-macrophage colony-stimulating factor, GM-CSF, (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery.


Participant Flow:   Overall Study
    Lymphodepleting Chemotherapy + High Dose Interleukin-2  
STARTED     20  
COMPLETED     18  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
screen failure                 1  



  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
Lymphodepleting Chemotherapy + High Dose IL-2 intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). GM-CSF (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery.

Baseline Measures
    Lymphodepleting Chemotherapy + High Dose IL-2  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     19  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  52  ± 11.3  
Gender  
[units: participants]
 
Female     3  
Male     17  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
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1.  Primary:   Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST   [ Time Frame: Response at 12 weeks ]

2.  Secondary:   Number of Participants With Lymphocyte Recovery as Measured by Blood Count   [ Time Frame: on days 1-15, weekly for 2 weeks, and then every 2-3 months ]

3.  Secondary:   Time to Progression as Measured by RECIST   [ Time Frame: From date of randomization until the first date of documented progression or date of death from any cause, which ever came first, assessed up till 100 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
This was the first stage of a two-stage phase II study and continuation to next stage required 4 of 18 particpant having an objective response. Only 3 objective responses were noted and the study was terminated at stage 1.


  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. Marc Ernstoff
Organization: Dartmouth-Hitchcock
phone: 603 650 5534
e-mail: marc.s.ernstoff@hitchcock.org


Publications of Results:

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00085423     History of Changes
Obsolete Identifiers: NCT00225771
Other Study ID Numbers: CDR0000370788, P30CA023108, DMS-0320, DMS-16531
Study First Received: June 10, 2004
Results First Received: January 26, 2012
Last Updated: April 9, 2013
Health Authority: United States: Federal Government