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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002882 |
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa plus combination chemotherapy and interleukin-2 is more effective than interferon alfa alone in treating patients with melanoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy plus interleukin-2 in treating patients with melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Biological: aldesleukin Biological: recombinant interferon alfa Drug: cisplatin Drug: dacarbazine Drug: vinblastine Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | ADJUVANT THERAPY FOR MELANOMA PATIENTS WITH REGIONAL LYMPH NODE METASTASES WITH INTERFERON ALFA-2B VS. BIOCHEMOTHERAPY USING CISPLATIN + VINBLASTINE + DTIC + INTERFERON PLUS IL-2 |
Estimated Enrollment: | 200 |
Study Start Date: | November 1995 |
OBJECTIVES:
OUTLINE: This is a randomized study. All patients are stratified according to prognostic factors.
Patients are randomly allocated to 1 of 2 treatment options. Treatment 1 uses interferon alfa-2b (IFN-A) therapy, and treatment 2 includes adjuvant biochemotherapy.
Patients who are randomized to IFN-A will be further stratified and randomized to one of two interferon schedules.
PROJECTED ACCRUAL: A total of 200 patients (100 patients in each arm) will be entered.
Ages Eligible for Study: | 10 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
No second malignancy except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Agop Y. Bedikian, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000065188, MDA-ID-95196, MDA-DM-95196, NCI-G96-1089 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002882 History of Changes |
Health Authority: | United States: Federal Government |
stage III melanoma |
Anti-Infective Agents Interferon Type I, Recombinant Dacarbazine Immunologic Factors Vinblastine Melanoma Anti-Retroviral Agents Cisplatin Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neoplasm Metastasis Neuroepithelioma Alkylating Agents Interferon-alpha Anti-HIV Agents |
Interferons Adjuvants, Immunologic Antimitotic Agents Antiviral Agents Angiogenesis Inhibitors Neuroendocrine Tumors Neuroectodermal Tumors Aldesleukin Radiation-Sensitizing Agents Interleukin-2 Tubulin Modulators Nevus Antineoplastic Agents, Alkylating Interferon Alfa-2a Antineoplastic Agents, Phytogenic |
Anti-Infective Agents Interferon Type I, Recombinant Dacarbazine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Vinblastine Melanoma Anti-Retroviral Agents Cisplatin Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas |
Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents Interferon-alpha Anti-HIV Agents Neoplasms by Histologic Type Growth Substances Mitosis Modulators Interferons Antimitotic Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors |