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

Merck Sharp & Dohme LLC299 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

299

Conditions

Melanoma

Interventions

Intron A (interferon alfa-2b; SCH 30500)BIOLOGICAL

The recommended regimen includes an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 million international units per square meter (MIU/m\^2). The induction treatment should be followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m\^2. Therapy should be administered for a total of one year unless the disease progresses or the treatment has lead to recurrent unmanageable serious adverse effects.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants Who Completed Treatment

Treatment completion was defined as those who completed both the induction and maintenance phases.

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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