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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Southwest Oncology Group Cancer and Leukemia Group B |
| Information provided by: | Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00003027 |
Purpose
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) |
Biological: aldesleukin Biological: filgrastim Biological: recombinant interferon alfa Drug: cisplatin Drug: dacarbazine Drug: vinblastine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
| Primary Completion Date: | July 2007 (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.
Eligibility| 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:
Contacts and Locations
Show 94 Study Locations| Study Chair: | Michael B. Atkins, MD | Tufts Medical Center |
| Study Chair: | Lawrence E. Flaherty, MD | Barbara Ann Karmanos Cancer Institute |
| Study Chair: | David M. Gustin, MD | University of Illinois |
More Information
| ClinicalTrials.gov Identifier: | NCT00003027 History of Changes |
| Other Study ID Numbers: | CDR0000065617, E3695, CLB-509802, SWOG-E3695 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 28, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
stage IV melanoma |
|
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 Lenograstim Cisplatin Dacarbazine |
Vinblastine 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 |