Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)

Completed

• Conditions: Melanoma

• Registration Number: NCT00723710
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose Intron A for one year. The objective of this study is to maximize treatment compliance by proactive management of side effects in a day-to-day healthcare setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2013-08-21
• Results First Submitted QC: 2013-08-21
• Results First Posted: 2013-10-28
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

Inclusion Criteria

• Signed informed consent
• Age > 18 years
• Confirmed melanoma
• Patient has been prescribed Intron A therapy for High-Risk Stage II & III Melanoma
• Intron A therapy started within 70 days of surgery (additional 15 days may be granted by the sponsor upon written approval)
• Proper contraception in both male and female subjects and the female partner(s) of male study subjects

Exclusion Criteria

• Metastatic disease at the time of diagnosis
• Other malignancies
• History of non compliance to other therapies
• Pregnancy or breast feeding
• Previous Intron A therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Completed Treatment	Up to 1 year	Treatment completion was defined as those who completed both the induction and maintenance phases.