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

NCT ID: NCT00723710

Last Updated: 2015-08-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 299 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2012-09-30

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.

Conditions

Melanoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Intron A

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

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

SCH 30500

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Levesque N, Mitchinson K, Lawrie D, Fedorak L, Macdonald D, Normand C, Pouliot JF. Health management program: factors influencing completion of therapy with high-dose interferon alfa-2b for high-risk melanoma. Curr Oncol. 2008 Jan;15(1):36-41. doi: 10.3747/co.2008.200.

Reference Type: RESULT

PMID: 18317583 (View on PubMed)

Other Identifiers

P04600

Identifier Type: -

Identifier Source: org_study_id