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
- Interventions
- Biological: Intron A (interferon alfa-2b; SCH 30500)
- 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
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
Read More
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
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intron A Intron A (interferon alfa-2b; SCH 30500) Patients with malignant melanoma who are free of disease post-surgery but at high risk for systemic recurrence.
- 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.
- Secondary Outcome Measures
Name Time Method