S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006237
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : September 19, 2012
Last Update Posted : March 25, 2015
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Children's Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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

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
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

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

Baseline Measures
   Interferon   Biochemotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 203   199   402 
[Units: Years]
Median (Full Range)
 (12 to 73) 
 (10 to 74) 
 (10 to 74) 
[Units: Participants]
Female   62   58   120 
Male   141   141   282 
Region of Enrollment 
[Units: Participants]
United States   203   199   402 

  Outcome Measures

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

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

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Southwest Oncology Group Identifier: NCT00006237     History of Changes
Obsolete Identifiers: NCT00546416
Other Study ID Numbers: S0008
U10CA032102 ( U.S. NIH Grant/Contract )
S0008 ( Other Identifier: SWOG )
CALGB-500002 ( Other Identifier: CALGB )
ECOG-S0008 ( Other Identifier: ECOG )
COG-S0008 ( Other Identifier: COG )
First Submitted: September 11, 2000
First Posted: January 27, 2003
Results First Submitted: August 20, 2012
Results First Posted: September 19, 2012
Last Update Posted: March 25, 2015