Melanoma (Skin) Clinical Trial
Official title:
A RANDOMISED STUDY OF OBSERVATION VERSUS ADJUVANT LOW DOSE EXTENDED DURATION INTERFERON ALPHA-2A IN COMPLETELY RESECTED HIGH RISK MALIGNANT MELANOMA
RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet
known whether interferon alfa following surgery is more effective than surgery alone in
treating patients with melanoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with no
further therapy following surgery in treating patients with stage II, stage III, or
recurrent melanoma.
OBJECTIVES: I. Determine the effects of adjuvant low-dose extended-duration interferon alfa
on disease-free and overall survival in patients with completely resected malignant melanoma
at high risk of recurrence. II. Determine any correlation between patient age or sex and the
effects of interferon therapy on disease-free and overall survival. III. Describe the toxic
effects of this treatment. IV. Evaluate the economic implications of implementing effective
interferon therapy in these patients.
OUTLINE: This is a randomized study. Patients will be stratified by age, sex, disease status
at entry, and participating institution. Patients are randomized to observation only or to
receive interferon alfa by subcutaneous injections 3 times weekly for 2 years, or until
disease progression or toxicity intervenes. Patients are followed monthly for 6 months,
quarterly for 18 months, and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 1,000 patients will be entered over 5 years.
;
Allocation: Randomized, Primary Purpose: Treatment
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