High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma

This study has been terminated.
(The third interim analysis showed that there was no evidence of benefit from treatment with interferon.)
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Southwest Oncology Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Children's Oncology Group
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier:
NCT00003641
First received: November 1, 1999
Last updated: March 31, 2016
Last verified: March 2016
Results First Received: February 2, 2016  
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: interferon alfa-2b
Other: observation

  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
The study was activated on December 22, 1998, and terminated on October 26, 2010 with final accrual of 1150 patients

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
Observation Patients undergo observation for 4 weeks.
Interferon Alfa-2b

Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.

interferon alfa-2b: Given IV


Participant Flow:   Overall Study
    Observation     Interferon Alfa-2b  
STARTED     569     581  
Treated     2 [1]   569  
Toxicity Assessed     439 [2]   568  
COMPLETED     0     407  
NOT COMPLETED     569     174  
Withdrawal by Subject                 0                 100  
Adverse Event                 0                 38  
Disease progression                 0                 2  
Unknown/missing                 0                 22  
Should not receive interferon therapy                 2                 0  
Never started interferon                 567                 12  
[1] Patients on arm I should undergo observation, but 2 patients received interferon therapy
[2] 439 patients on arm I had their toxicity assessed even though they did not receive any treatment



  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.
All randomized patients

Reporting Groups
  Description
Observation Patients undergo observation for 4 weeks.
Interferon Alfa-2b

Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.

interferon alfa-2b: Given IV

Total Total of all reporting groups

Baseline Measures
    Observation     Interferon Alfa-2b     Total  
Number of Participants  
[units: participants]
  569     581     1150  
Age  
[units: years]
Median (Full Range)
  52  
  (19 to 81)  
  52  
  (10 to 85)  
  52  
  (10 to 85)  
Gender [1]
[units: participants]
     
Female     248     244     492  
Male     320     336     656  
[1] 1 patient on arm I and 1 patient on arm II had missing information about sex



  Outcome Measures
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1.  Primary:   5-year Relapse-free Survival Rate   [ Time Frame: assessed every 3 months for 2 years, every 6 months for 3 years ]

2.  Secondary:   5-year Overall Survival Rate   [ Time Frame: assessed every 3 months for 2 years, every 6 months for 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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study statistician
Organization: ECOG-ACRIN Statistical Office
phone: 617-632-3012



Responsible Party: Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier: NCT00003641     History of Changes
Other Study ID Numbers: E1697
E1697 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA023318 ( US NIH Grant/Contract Award Number )
CDR0000066727 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: November 1, 1999
Results First Received: February 2, 2016
Last Updated: March 31, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration