S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma

Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa is more effective with or without combination chemotherapy and interleukin-2 for melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy consisting of cisplatin, vinblastine, and dacarbazine, plus interleukin-2, in treating patients who have melanoma.

Conditions

• Melanoma (Skin)

Interventions

BIOLOGICAL

interleukin-2

Given IV

BIOLOGICAL

filgrastim

Given subcutaneously

BIOLOGICAL

interferon alfa

Given IV and subcutaneously

DRUG

cisplatin

Given IV

DRUG

dacarbazine

Given IV

DRUG

vinblastine

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Eastern Cooperative Oncology Group

  collaborator NETWORK

• Cancer and Leukemia Group B

  collaborator NETWORK

• Children's Oncology Group

  collaborator NETWORK

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

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

• John A. Thompson, MD · Seattle Cancer Care Alliance

• John T. Vetto, MD, FACS · OHSU Knight Cancer Institute

• Michael B. Atkins, MD · Beth Israel Deaconess Medical Center

• John M. Kirkwood, MD · University of Pittsburgh

• Frank Haluska, MD, PhD · Massachusetts General Hospital

• 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

2000-08-31

Primary Completion

2012-07-31

Completion

2012-07-31

Countries

• United States
• Australia

Study Locations