Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma

Phase 2

Completed

• Conditions: Melanoma (Skin)

• Registration Number: NCT00002669
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.

Detailed Description

OBJECTIVES:

* Assess the rate of disease stabilization in patients with metastatic melanoma when treated with interferon alfa, dacarbazine, cisplatin, and interleukin-2.

* Assess toxicity, overall response rate, and response duration in these patients when treated with this regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive dacarbazine IV over 1 hour and cisplatin IV over 3 hours on days 1-3. Patients also receive interferon alfa subcutaneously (SQ) on days 1-5 and interleukin-2 by continuous IV infusion on days 4-9. Treatment continues every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.

* Arm II: Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses. Patients then receive treatment as in arm I for a maximum of 4 courses.

Patients are followed every 2 months for 6 months, then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 42-90 patients will be accrued for this study.

Study Timeline

• Study Start: 1995-06
• Study First Submitted: 2000-06-02
• Primary Completion: 2002-08
• Study First Submitted QC: 2003-04-10
• Study First Posted: 2003-04-11
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (24)

Istituto Europeo Di Oncologia; 🇮🇹 Milano, Italy

Landeskrankenanstalten - Salzburg; 🇦🇹 Salzburg, Austria

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Institut Jules Bordet; 🇧🇪 Brussels (Bruxelles), Belgium

CHR de Besancon - Hopital Saint-Jacques; 🇫🇷 Besancon, France

CHU Pitie-Salpetriere; 🇫🇷 Paris, France

Centre Leon Berard; 🇫🇷 Lyon, France

Universitaetsklinikum Charite; 🇩🇪 Berlin, Germany

Universitaetsklinikum Benjamin Franklin; 🇩🇪 Berlin, Germany

Haematologisch-Onkologische Praxis Altona; 🇩🇪 Hamburg, Germany

Robert Roessle Klinik; 🇩🇪 Berlin, Germany

Universitaetsspital; 🇨🇭 Zurich, Switzerland

Johannes Gutenberg University; 🇩🇪 Mainz, Germany

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

Rotterdam Cancer Institute; 🇳🇱 Rotterdam, Netherlands

III Medizinische Klinik Mannheim; 🇩🇪 Mannheim, Germany

Instituto Portugues de Oncologia do Porto; 🇵🇹 Porto, Portugal

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Royal Marsden NHS Trust; 🇬🇧 London, England, United Kingdom

Southend NHS Trust Hospital; 🇬🇧 Westcliff-On-Sea, England, United Kingdom

St. James's Hospital; 🇬🇧 Leeds, England, United Kingdom

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium