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Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00749684
First Posted: September 9, 2008
Last Update Posted: October 19, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: 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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp and Dohme Corp.
phone: 1-800-672-6372
e-mail: clinicaltrialsdisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00749684     History of Changes
Other Study ID Numbers: P04083
First Submitted: September 8, 2008
First Posted: September 9, 2008
Results First Submitted: October 22, 2010
Results First Posted: March 24, 2011
Last Update Posted: October 19, 2015