NCT00003641

High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma

Phase III Randomized Study of Four Weeks of High Dose Interferon Alfa-2b in Stage T2bN0, T3a-bN0, T4a-bN0, and T1-4, N1a,2a (Microscopic) Melanoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,150 (actual)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically. PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.

Detailed description

OBJECTIVES: Primary Objective: * Compare the effect of high-dose interferon alfa-2b treatment on the relapse-free survival of patients with stage II or III resected malignant melanoma. Secondary Objectives: * Compare the effect of this treatment regimen on overall survival of these patients. * Assess the toxicity of this treatment in these patients. * Compare the effect of treatment on quality of life. OUTLINE: This is a randomized study. Patients are stratified by pathologic lymph node status (known vs unknown),lymph node staging procedures(sentinel lymph node procedure vs. elective lymph node dissection vs. no lymphadenectomy), Breslow depth (\<= 1.0 mm vs. 1.01-2.0 mm vs. 2.01-4.0 mm vs \> 4.0 mm), ulceration of the primary lesion (yes vs. no vs. unknown), and disease stage (lymph node positive \[N1, N2a\] vs. lymph node negative \[N0\]). Patients are randomized into one of two treatment arms in a 1:1 ratio. * Arm I (observation): Patients undergo observation for 4 weeks. * Arm II (Interferon Alfa-2b): Patients receive high-dose interferon alfa-2b intravenously (IV) over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity. Quality of life is assessed before treatment, at day 22, every 3 months for 2 years, and then every 6 months for 3 years. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter until 15 years after randomization. PROJECTED ACCRUAL: A total of 1,420 patients will be accrued for this study over 5 years.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	interferon alfa-2b	Given IV
OTHER	observation	Patients undergo observation for 4 weeks.

Timeline

• Start date: 1999-03-25
• Primary completion: 2015-01-01
• Completion: 2026-12-01
• First posted: 2003-01-27
• Last updated: 2026-02-25
• Results posted: 2016-05-04

Locations

533 sites across 4 countries: United States, Australia, Canada, South Africa