Melanoma (Skin) Clinical Trial
Official title:
POST-OPERATIVE ADJUVANT INTERFERON-ALFA-2B (INTRON-A) TREATMENT AFTER RESECTION OF THICK PRIMARY MELANOMA AND/OR REGIONAL LYMPHNODE METASTASES 'INTERMEDIATE-HIGH DOSE' VS INTERMEDIATE-LOW DOSE' IFN-ALFA VS OBSERVATION: A 3-ARM MULTICENTER RANDOMIZED PHASE III TRIAL
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not known
whether giving high-dose or low-dose interferon alfa is more effective than no further
therapy in treating patients with stage III melanoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of high- or low-dose
interferon alfa with that of no further therapy following surgery in treating patients who
have stage III melanoma.
OBJECTIVES: I. Evaluate the time to distant metastasis, death due to melanoma, and overall
survival in patients with high-risk stage III melanoma treated with 10 MU of interferon alfa
(IFN-A) for 4 weeks followed by 1 year of IFN-A at 10 MU three times per week vs. 2 years of
IFN-A at 5 MU three times per week vs. observation alone. II. Assess the toxicity associated
with IFN-A. III. Compare the quality of life, costs, and compliance associated with each
treatment regimen.
OUTLINE: Randomized study. Following definitive surgical resection, patients are randomly
assigned in a 2:2:1 ratio to Arms A, B, and C, respectively. Arm A: Biological Response
Modifier Therapy. Interferon alfa-2b (Schering), IFN-A, NSC-377523. Higher dose. Arm B:
Biological Response Modifier Therapy. IFN-A. Lower dose. Arm C: Control. Observation.
PROJECTED ACCRUAL: A total of 1,000 patients will be entered over approximately 4 years in
this multicenter study.
;
Allocation: Randomized, Primary Purpose: Treatment
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