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

June 29, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, A-5020
        • Landeskrankenanstalten - Salzburg
  • Belgium
      • Brussels, Belgium, 1070
        • Hopital Universitaire Erasme
      • Brussels (Bruxelles), Belgium, 1000
        • Institut Jules Bordet
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • France
      • Besancon, France, 25030
        • CHR de Besancon - Hopital Saint-Jacques
      • Lyon, France, 69373
        • Centre Leon Berard
      • Paris, France, 75651
        • CHU Pitié-Salpêtrière
  • Germany
      • Berlin, Germany, D-12200
        • Universitaetsklinikum Benjamin Franklin
      • Berlin, Germany, D-10117
        • Universitaetsklinikum Charite
      • Berlin, Germany, D-13122
        • Robert Roessle Klinik
      • Hamburg, Germany, D-22765
        • Haematologisch-Onkologische Praxis Altona
      • Mainz, Germany, D-55101
        • Johannes Gutenberg University
      • Mannheim, Germany, D-68135
        • III Medizinische Klinik Mannheim
  • Italy
      • Milano, Italy, 20141
        • Istituto Europeo Di Oncologia
  • Netherlands
      • Nijmegen, Netherlands, NL-6500 HB
        • University Medical Center Nijmegen
      • Rotterdam, Netherlands, 3075 EA
        • Rotterdam Cancer Institute
  • Portugal
      • Porto, Portugal, 4200
        • Instituto Portugues de Oncologia do Porto
  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • Zurich, Switzerland, CH-8091
        • UniversitaetsSpital
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
    • England
      • Leeds, England, United Kingdom, LS9 7TF
        • St. James's Hospital
      • London, England, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Trust
      • Westcliff-On-Sea, England, United Kingdom
        • Southend NHS Trust Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed melanoma that is metastatic and unresectable

  • Measurable, progressive disease (by physical exam and/or noninvasive imaging)

    • No prior irradiation of indicator lesions
  • No CNS metastases (confirmed by CT or MRI)

PATIENT CHARACTERISTICS:

Age:

  • 18 to 70

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Greater than 3 months

Hematopoietic:

  • WBC at least 2,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • No serious hepatic disease

Renal:

  • Creatinine no greater than 1.65 mg/dL
  • No serious renal disease

Cardiovascular:

  • No serious cardiac disease

Pulmonary:

  • No serious pulmonary disease

Other:

  • No organ allograft
  • No autoimmune disease
  • No uncontrolled infection
  • No active peptic ulcer
  • No hyper or hypothyroidism
  • No requirement for corticosteroids
  • No second malignancy except basal cell skin carcinoma or carcinoma in situ of the cervix
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy with interleukin-2
  • No prior interferon alfa in combination with cisplatin or dacarbazine

Chemotherapy:

  • No prior chemotherapy with cisplatin in combination with dacarbazine
  • More than 3 months since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior radiotherapy allowed

Surgery:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Ulrich Keilholz, MD, Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1995

Primary Completion (Actual)

August 1, 2002

Study Registration Dates

First Submitted

June 2, 2000

First Submitted That Met QC Criteria

April 10, 2003

First Posted (Estimate)

April 11, 2003

Study Record Updates

Last Update Posted (Estimate)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-18951

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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