Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma
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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 |
| Estimated Enrollment: | 90 |
| Study Start Date: | June 1995 |
| Primary Completion Date: | August 2002 (Final data collection date for primary outcome measure) |
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 |
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| 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 | |
| Universitaetsklinikum Benjamin Franklin | |
| Berlin, Germany, D-12200 | |
| Universitaetsklinikum Charite | |
| Berlin, Germany, D-10117 | |
| Robert Roessle Klinik | |
| Berlin, Germany, D-13122 | |
| 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 | |
| Study Chair: | Ulrich Keilholz, MD | Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin |
More Information
Additional Information:
Publications:
| 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 Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Interferon-alpha Interferon Alfa-2a Interferons Aldesleukin Cisplatin Dacarbazine Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Radiation-Sensitizing Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 21, 2013