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

NCT00002669 | Completed Phase 2

• 1 other identifier: EORTC-18951
• Study Type: interventional
• Target: 90
• Locations: 9 countries
• Sites: 24

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Interventions

aldesleukin BIOLOGICAL

recombinant interferon alfa BIOLOGICAL

cisplatin DRUG

dacarbazine DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (24)

Landeskrankenanstalten - Salzburg

Salzburg, A-5020, Austria

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Institut Jules Bordet

Brussels (Bruxelles), 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

CHR de Besancon - Hopital Saint-Jacques

Besançon, 25030, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Universitaetsklinikum Charite

Berlin, D-10117, Germany

Location

Universitaetsklinikum Benjamin Franklin

Berlin, D-12200, Germany

Location

Robert Roessle Klinik

Berlin, D-13122, Germany

Location

Haematologisch-Onkologische Praxis Altona

Hamburg, D-22765, Germany

Location

Johannes Gutenberg University

Mainz, D-55101, Germany

Location

III Medizinische Klinik Mannheim

Mannheim, D-68135, Germany

Location

Istituto Europeo Di Oncologia

Milan, 20141, Italy

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Rotterdam Cancer Institute

Rotterdam, 3075 EA, Netherlands

Location

Instituto Portugues de Oncologia do Porto

Porto, 4200, Portugal

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Universitaetsspital

Zurich, CH-8091, Switzerland

Location

St. James's Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Royal Marsden NHS Trust

London, England, SW3 6JJ, United Kingdom

Location

Southend NHS Trust Hospital

Westcliff-on-Sea, England, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Related Publications (7)

• Agarwala SS, Keilholz U, Gilles E, Bedikian AY, Wu J, Kay R, Stein CA, Itri LM, Suciu S, Eggermont AM. LDH correlation with survival in advanced melanoma from two large, randomised trials (Oblimersen GM301 and EORTC 18951). Eur J Cancer. 2009 Jul;45(10):1807-14. doi: 10.1016/j.ejca.2009.04.016. Epub 2009 May 4.

  PMID: 19419855 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10685668 BACKGROUND

• 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. doi: 10.1200/JCO.2006.09.0274.

  PMID: 17443000 RESULT

• 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. doi: 10.1016/j.ejca.2006.08.012. Epub 2006 Oct 4.

  PMID: 17023156 RESULT

• 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. doi: 10.1200/JCO.2005.03.202.

  PMID: 16170182 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; Interferon-alpha; Cisplatin; Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ulrich Keilholz, MD

  Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: April 11, 2003
• Study Start: June 1, 1995
• Primary Completion: August 1, 2002
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

GB (4); BE (4); CH (2); PT (1); AU (1); IT (1); FR (3); NL (2); DE (6)