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Sponsors and Collaborators: |
Norris Comprehensive Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00031733 |
RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
Condition | Intervention | Phase |
---|---|---|
Intraocular Melanoma Melanoma (Skin) |
Drug: MART-1 antigen Drug: alum adjuvant Drug: gp100 antigen Drug: incomplete Freund's adjuvant Drug: recombinant interleukin-12 Drug: sargramostim Drug: tyrosinase peptide Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase II Randomized Trial of a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With Interleukin-12 With Alum or GM-CSF for Patients With Resected Stages IIB/C, III and IV Melanoma |
Study Start Date: | February 2002 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to disease stage (cutaneous stage IIB, IIC, III, and IV vs ocular and mucosal stage III and IV). Patients are randomized to 1 of 3 treatment arms.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of stage IIB, IIC, III, or IV cutaneous melanoma OR stage III or IV ocular or mucosal melanoma
Tumor tissue must be available for analysis of gp100 staining and tyrosinase and MART-1 expression by immunohistochemistry
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Immunologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90089 |
Study Chair: | Jeffrey S. Weber, MD, PhD | Norris Comprehensive Cancer Center |
Study ID Numbers: | CDR0000069220, LAC-USC-10M011, LAC-USC-IRB-013030, NCI-5506 |
Study First Received: | March 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00031733 |
Health Authority: | United States: Federal Government |
iris melanoma ciliary body and choroid melanoma, small size ciliary body and choroid melanoma, medium/large size extraocular extension melanoma recurrent intraocular melanoma |
stage II melanoma stage III melanoma stage IV melanoma recurrent melanoma |
Interleukin-12 Eye Neoplasms Eye Diseases Recurrence Melanoma Neuroendocrine Tumors Melanoma of the choroid Neuroectodermal Tumors |
Uveal melanoma Aluminum sulfate Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular melanoma Neuroepithelioma Freund's Adjuvant Nevus |
Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Adjuvants, Immunologic Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Nevi and Melanomas Angiogenesis Modulating Agents Growth Inhibitors |