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Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma
This study is ongoing, but not recruiting participants.
Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002669
  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)
Drug: aldesleukin
Drug: cisplatin
Drug: dacarbazine
Drug: recombinant interferon alfa
Phase II

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Cisplatin Aldesleukin Dacarbazine Interferon alfa-n1 Interferon alfa-2a Interferons Interleukin-2
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 90
Study Start Date: June 1995
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
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
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
France
Centre Leon Berard
Lyon, France, 69373
CHR de Besancon - Hopital Saint-Jacques
Besancon, France, 25030
CHU Pitie-Salpetriere
Paris, France, 75651
Germany
Haematologisch-Onkologische Praxis Altona
Hamburg, Germany, D-22765
III Medizinische Klinik Mannheim
Mannheim, Germany, D-68135
Johannes Gutenberg University
Mainz, Germany, D-55101
Robert Roessle Klinik
Berlin, Germany, D-13122
Universitaetsklinikum Benjamin Franklin
Berlin, Germany, D-12200
Universitaetsklinikum Charite
Berlin, Germany, D-10117
Italy
Istituto Europeo Di Oncologia
Milano, Italy, 20141
Netherlands
Rotterdam Cancer Institute
Rotterdam, Netherlands, 3075 EA
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
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
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
United Kingdom, England
Royal Marsden NHS Trust
London, England, United Kingdom, SW3 6JJ
Southend NHS Trust Hospital
Westcliff-On-Sea, England, United Kingdom
St. James's Hospital
Leeds, England, United Kingdom, LS9 7TF
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Study Chair: Ulrich Keilholz, MD Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Schmidt H, Suciu S, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, von der Maase H, Eggermont AM, Keilholz U; American Joint Committee on Cancer Stage IV Melanoma; EORTC 18951. Pretreatment levels of peripheral neutrophils and leukocytes as independent predictors of overall survival in patients with American Joint Committee on Cancer Stage IV Melanoma: results of the EORTC 18951 Biochemotherapy Trial. J Clin Oncol. 2007 Apr 20;25(12):1562-9.
Punt CJ, Suciu S, Gore MA, Koller J, Kruit WH, Thomas J, Patel P, Lienard D, Eggermont AM, Keilholz U. Chemoimmunotherapy with dacarbazine, cisplatin, interferon-alpha2b and interleukin-2 versus two cycles of dacarbazine followed by chemoimmunotherapy in patients with metastatic melanoma: a randomised phase II study of the European Organization for Research and Treatment of Cancer Melanoma Group. Eur J Cancer. 2006 Nov;42(17):2991-5. Epub 2006 Oct 4.
Keilholz U, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, Thomas J, Proebstle TM, Schmittel A, Schadendorf D, Velu T, Negrier S, Kleeberg U, Lehman F, Suciu S, Eggermont AM. Dacarbazine, cisplatin, and interferon-alfa-2b with or without interleukin-2 in metastatic melanoma: a randomized phase III trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol. 2005 Sep 20;23(27):6747-55.
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.

Other Publications:
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.
Keilholz U, Eggermont AM. The role of interleukin-2 in the management of stage IV melanoma: the EORTC melanoma cooperative group program. Cancer J Sci Am. 2000 Feb;6 Suppl 1:S99-103.

Study ID Numbers: CDR0000064258, EORTC-18951
Study First Received: June 2, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002669  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Dacarbazine
Interferons
Recurrence
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Aldesleukin
Cisplatin
Interleukin-2
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Nevus
Interferon Alfa-2a

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Anti-Retroviral Agents
Therapeutic Uses
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Growth Inhibitors
Angiogenesis Modulating Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009