MedTrace Logo

Combination Chemotherapy With or Without Interleukin-2 and Interferon Alfa in Treating Patients With Metastatic Melanoma

NCT00003027 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2023-06-22

No results posted yet for this study

Summary

RATIONALE: 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. Interferon alfa may interfere with the growth of tumor cells. It is not yet known whether combination chemotherapy plus interleukin-2 and interferon alfa is more effective than combination chemotherapy alone for metastatic melanoma.

PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that cannot be treated by surgery.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

aldesleukin

BIOLOGICAL

filgrastim

BIOLOGICAL

recombinant interferon alfa

DRUG

cisplatin

DRUG

dacarbazine

DRUG

vinblastine

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    collaborator NETWORK

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Michael B. Atkins, MD · Tufts Medical Center

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

  • David M. Gustin, MD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-11-13
Primary Completion
2007-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003027 on ClinicalTrials.gov