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 (MSD)

Status: Completed

Conditions: Melanoma

Treatments: Biological: Intron A (interferon alfa-2b; SCH 30500)

Study type: Observational

Funder types: Industry

Identifiers

NCT00723710

P04600

Details and patient eligibility

About

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.

Enrollment: 299 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

299 participants in 1 patient group

Intron A

Description:

Patients with malignant melanoma who are free of disease post-surgery but at high risk for systemic recurrence.

Treatment:

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