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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00002669
First received: June 2, 2000
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Biological: aldesleukin
Biological: recombinant interferon alfa
Drug: cisplatin
Drug: dacarbazine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Estimated Enrollment: 90
Study Start Date: June 1995
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002669

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

Additional Information:
Publications:
Keilholz U, Punt CJ, Gore M, et al.: Dacarbazine, cisplatin and interferon alpha with or without interleukin-2 in advanced melanoma: interim analysis of EORTC trial 18951. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A2043, 530a, 1999.
Keilholz U, Suciu S, Bedikian AY, et al.: LDH is a prognostic factor in stage IV melanoma patients (pts) but is a predictive factor only for bcl2 antisense treatment efficacy: re-analysis of GM301 and EORTC18951 randomized trials. [Abstract] J Clin Oncol 25 (Suppl 18): A-8552, 485s, 2007.

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00002669     History of Changes
Other Study ID Numbers: EORTC-18951, EORTC-18951
Study First Received: June 2, 2000
Last Updated: June 29, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Interferon-alpha
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014