Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083AM1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00749684
First received: September 8, 2008
Last updated: April 28, 2014
Last verified: April 2014
Results First Received: October 22, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Melanoma
Intervention: Biological: Interferon α-2b

  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
Male and female participants, with malignant melanoma Stage II or III (>1.5 mm tumor thickness, no distant metastasis) or malignant melanoma with evidence of lymph node metastis or lymph node metastasis of malignant melanoma at unknown primary tumor, primary tumor has to be surgically resected within 2 months after first biopsy/excision.

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
Adults With Malignant Melanoma at High Risk of Relapse

Adults with malignant melanoma of the following stages:

  • II and III (>/= 1.5 mm Breslow thickness without distant metastases
  • melanoma with lymph node metastases

Participant Flow:   Overall Study
    Adults With Malignant Melanoma at High Risk of Relapse  
STARTED     138  
COMPLETED     56  
NOT COMPLETED     82  
Death                 1  
Adverse Event                 27  
Participant's Wish                 10  
Not Documented                 1  
Progressive Desease                 31  
Therapy according to protocol + AE                 2  
AE+discontinuation on participants wish                 1  
Missing                 9  



  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
Adults With Malignant Melanoma at High Risk of Relapse

Adults with malignant melanoma of the following stages:

  • II and III (>/= 1.5 mm Breslow thickness without distant metastases
  • melanoma with lymph node metastases

Baseline Measures
    Adults With Malignant Melanoma at High Risk of Relapse  
Number of Participants  
[units: participants]
  138  
Age  
[units: participants]
Median ± Standard Deviation
 
Total     48.83  ± 12.72  
Male     49.15  ± 12.91  
Female     48.27  ± 12.49  
Gender  
[units: participants]
 
Female     50  
Male     88  



  Outcome Measures
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1.  Primary:   Number of Participants With Disease Recurrence   [ Time Frame: Throughout 12 months of treatment and 24 months of follow-up ]

2.  Primary:   Relapse Free Survival Time   [ Time Frame: Throughout 12 months of treatment and 24 months of follow-up ]


  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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp and Dohme Corp.
phone: 1-800-672-6372
e-mail: clinicaltrialsdisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00749684     History of Changes
Other Study ID Numbers: P04083
Study First Received: September 8, 2008
Results First Received: October 22, 2010
Last Updated: April 28, 2014
Health Authority: Austria: Agency for Health and Food Safety