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

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.

Conditions

• Melanoma (Skin)

Interventions

BIOLOGICAL

interferon alfa-2b

Given IV

OTHER

observation

Patients undergo observation for 4 weeks.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• SWOG Cancer Research Network

  collaborator NETWORK

• Cancer and Leukemia Group B

  collaborator NETWORK

• NCIC Clinical Trials Group

  collaborator NETWORK

• Children's Oncology Group

  collaborator NETWORK

• ECOG-ACRIN Cancer Research Group

  lead NETWORK

Principal Investigators

• Sanjiv S. Agarwala, MD · St. Luke's Cancer Network at St. Luke's Hospital

• John M. Kirkwood, MD · UPMC Cancer Center at UPMC Presbyterian

• Lawrence E. Flaherty, MD · Barbara Ann Karmanos Cancer Institute

• William E. Carson, MD · Ohio State University Comprehensive Cancer Center

• Michael Smylie, MD, MB, ChB · Cross Cancer Institute at University of Alberta

• Alberto S. Pappo, MD · Texas Children's Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1999-03-25

Primary Completion

2015-01-31

Completion

2026-12-31

Countries

• United States
• Australia
• Canada
• South Africa

Study Locations