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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: | NCT00085189 |
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Combining a vaccine with Montanide ISA-51 and ISA 51 VG and CpG 7909 may cause a stronger immune response and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving peptide vaccine together with Montanide ISA 51 and ISA 51 VG and CpG 7909 works in treating patients with stage IIC, stage III, or stage IV melanoma that has been completely resected.
Condition | Intervention | Phase |
---|---|---|
Intraocular Melanoma Melanoma (Skin) |
Drug: agatolimod sodium Drug: gp100 antigen Drug: incomplete Freund's adjuvant Drug: recombinant MAGE-3.1 antigen Drug: tyrosinase peptide Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of a Vaccine Combining Multiple Class I Peptides With Montanide ISA 51 and ISA 51 VG and CpG Adjuvant 7909 for Patients With Resected Stages IIC/III and IV Melanoma |
Study Start Date: | May 2004 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a pilot study. Patients are stratified according to class I haplotype (HLA-A1 vs HLA-A3/A11).
Patients receive gp100 antigen, MAGE-3, tyrosinase peptide, Montanide ISA 51 and ISA 51 VG, and CpG 7909 subcutaneously on weeks 0, 2, 4, 6, 8, 10, 14, 18, 22, 26, 38, 50, and then every 6 months for 2 years (for a total of 16 vaccinations) in the absence of unacceptable toxicity.
Patients are followed every 6 months for 3 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 42 patients (21 per stratum) will be accrued for this study within 1-2 years.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of melanoma
Must be HLA-A1 or -A3/A11 positive by standard DNA-polymerase chain reaction assay AND HLA-B44 status known
Meets 1 of the following conditions for interferon alfa (IFN-α) therapy:
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 |
Principal Investigator: | Jeffrey S. Weber, MD, PhD | Norris Comprehensive Cancer Center |
Study ID Numbers: | CDR0000367485, LAC-USC-10M033, LAC-USC-IRB-942010, NCI-6451 |
Study First Received: | June 10, 2004 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00085189 |
Health Authority: | United States: Federal Government |
stage II melanoma stage III melanoma stage IV melanoma |
iris melanoma ciliary body and choroid melanoma, medium/large size extraocular extension melanoma |
Eye Neoplasms Eye Diseases Melanoma Neuroendocrine Tumors Melanoma of the choroid Neuroectodermal Tumors Uveal melanoma |
Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular melanoma Neuroepithelioma Freund's Adjuvant Nevus |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Adjuvants, Immunologic Nevi and Melanomas Pharmacologic Actions |