S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Children's Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00006237
First received: September 11, 2000
Last updated: November 15, 2012
Last verified: November 2012
Results First Received: August 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma (Skin)
Interventions: Biological: interleukin-2
Biological: filgrastim
Biological: interferon alfa
Drug: cisplatin
Drug: dacarbazine
Drug: vinblastine

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Interferon interferon alfa IV
Biochemotherapy cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim

Participant Flow:   Overall Study
    Interferon     Biochemotherapy  
STARTED     212     220  
Eligible     203     200  
Eligible and Treated     203     199  
COMPLETED     87     159  
NOT COMPLETED     125     61  
Adverse Event                 39                 29  
Death                 1                 0  
Refusal unrelated to adverse effects                 8                 4  
Progression/relapse                 54                 2  
Not eligible                 9                 20  
Withdrawal by Subject                 0                 1  
Not protocol specified                 14                 5  



  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.
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Reporting Groups
  Description
Interferon interferon alfa
Biochemotherapy cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
Total Total of all reporting groups

Baseline Measures
    Interferon     Biochemotherapy     Total  
Number of Participants  
[units: participants]
  203     199     402  
Age  
[units: years]
Median ( Full Range )
  47  
  ( 12 to 73 )  
  46  
  ( 10 to 74 )  
  47  
  ( 10 to 74 )  
Gender  
[units: participants]
     
Female     62     58     120  
Male     141     141     282  
Region of Enrollment  
[units: participants]
     
United States     203     199     402  



  Outcome Measures
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1.  Primary:   5-year Overall Survival   [ Time Frame: Every three months for a year, every six months for years 2-5, annual for years 5-10 ]

2.  Primary:   5-year Relapse-Free Survival   [ Time Frame: Every three months for the first year, every 6 months for years 2-5, annually for years 6-10 ]

3.  Secondary:   Toxicity   [ Time Frame: While on treatment, patients on the HDIFN arm were assessed weekly for the 1st month, then every 2 weeks for the 2nd month, then every 3 months therafter; patients on the biochemo arm were assessed daily for the 1st 5 days, then weekly thereafter. ]


  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: SWOG Melanoma Statistician
Organization: SWOG statistical office
phone: 206-667-4408


No publications provided


Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00006237     History of Changes
Obsolete Identifiers: NCT00546416
Other Study ID Numbers: CDR0000068162, U10CA032102, S0008, CALGB-500002, ECOG-S0008, COG-S0008
Study First Received: September 11, 2000
Results First Received: August 20, 2012
Last Updated: November 15, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration