Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) Southwest Oncology Group Cancer and Leukemia Group B |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003027 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Interferon alfa may interfere with the growth of tumor cells. It is not yet known whether combination chemotherapy plus interleukin-2 and interferon alfa is more effective than combination chemotherapy alone for metastatic melanoma.
PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that cannot be treated by surgery.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: aldesleukin Drug: cisplatin Drug: dacarbazine Drug: filgrastim Drug: recombinant interferon alfa Drug: vinblastine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase III Trial of Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon A-2B Versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients With Metastatic Malignant Melanoma |
Estimated Enrollment: | 482 |
Study Start Date: | October 1997 |
Estimated Primary Completion Date: | August 1999 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to performance status (0 vs 1), prior interferon (yes vs no), and number of involved sites. Patients are randomized to one of two treatment arms.
Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 6 weeks, every 3 months for 18 months, every 6 months for 18 months, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 482 patients will be accrued for this study within 3.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Normal cardiac stress test required for the following:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Michael B. Atkins, MD | Tufts-NEMC Cancer Center |
Study Chair: | Lawrence E. Flaherty, MD | Barbara Ann Karmanos Cancer Institute |
Study Chair: | David M. Gustin, MD | University of Illinois |
Study ID Numbers: | CDR0000065617, E-E3695, CLB-509802, SWOG-E3695 |
Study First Received: | November 1, 1999 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00003027 |
Health Authority: | United States: Federal Government |
stage IV melanoma |
Interferon-alpha Interferon Type I, Recombinant Dacarbazine Interferons Vinblastine Melanoma Neuroendocrine Tumors Neuroectodermal Tumors |
Aldesleukin Cisplatin Interleukin-2 Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Nevus Interferon Alfa-2a |
Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Anti-Retroviral Agents Therapeutic Uses Nevi and Melanomas Angiogenesis Modulating Agents Growth Inhibitors Alkylating Agents Neoplasms by Histologic Type |
Anti-HIV Agents Growth Substances Mitosis Modulators Antimitotic Agents Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Tubulin Modulators Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic |