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Sponsors and Collaborators: |
University of Illinois National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003568 |
RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.
PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with interleukin-2 in treating patients with metastatic melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: aldesleukin Drug: gp100 antigen Drug: incomplete Freund's adjuvant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase II Trial of a Mutated gp100 Melanoma Peptide (g209-217(210M) With Hight Dose Interleukin-2 (IL-2) in HLA-A2.1+Patients With Metastatic Melanoma |
Study Start Date: | November 1998 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior therapy (adjuvant interferon vs chemotherapy for advanced disease vs both vs none), ECOG performance status (0 vs 1), and number of organ sites involved (1 vs more than 1). Patients are randomized into 1 of 3 treatment arms. (Arm III closed to accrual as of 11/30/1998.)
Patients in each arm may receive up to a total of 3 courses of treatment.
Patients are followed until death.
PROJECTED ACCRUAL: Approximately 90 patients (25 patients for arms I and II and 40 patients for arm III [arm III closed to accrual as of 11/30/1998]) will be accrued for this study within 12-18 months.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No active brain metastases, leptomeningeal disease, or seizure disorder
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-0269 | |
United States, Illinois | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
University of Illinois at Chicago Health Sciences Center | |
Chicago, Illinois, United States, 60612 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, New York | |
Comprehensive Cancer Center at Our Lady of Mercy Medical CenterOur | |
Bronx, New York, United States, 10466 | |
United States, Pennsylvania | |
University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15236 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232-2516 | |
United States, Texas | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78229-3900 |
Study Chair: | David M. Gustin, MD | University of Illinois |
Study ID Numbers: | CDR0000066634, CWG-UIC-T98-0027, NCI-T98-0027 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003568 |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Aldesleukin Interleukin-2 Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Freund's Adjuvant Nevus Recurrence Neuroendocrine Tumors Melanoma |
Anti-Infective Agents Anti-HIV Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Adjuvants, Immunologic Antiviral Agents Pharmacologic Actions |
Neoplasms Anti-Retroviral Agents Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Nevi and Melanomas Peripheral Nervous System Agents Analgesics Central Nervous System Agents |