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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001685 |
Purpose
This is a study of a melanoma tumor antigen peptide vaccine. Peptides representing HLA-A201 restricted T cell epitopes of the melanoma antigens, MART-1, gp100 and tyrosinase will be administered emulsified in Incomplete Freund's Adjuvant, (IFA) to HLA-A201 patients with melanoma. The study is designed to evaluate the potential therapeutic role, immunologic effects and toxicity of repeated doses of this peptide vaccine administered subcutaneously.
Immune reactivity to the peptide epitope will be monitored in all patients by analysis of melanoma-specific T cell precursors prior to and after immunization.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma Neoplasm Metastasis |
Biological: Immunodominant peptides from three melanoma antigens, MART-1, GP100 and tyrosinase |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment |
| Official Title: | Immunization of HLA-A201 Patients With Metastatic Melanoma Using a Combination of Immunodominant Peptides From Three Melanoma Antigens, MART-1, GP100 and Tyrosinase |
| Estimated Enrollment: | 114 |
| Study Start Date: | November 1997 |
| Estimated Study Completion Date: | September 2000 |
This is a study of a melanoma tumor antigen peptide vaccine. Peptides representing HLA-A201 restricted T cell epitopes of the melanoma antigens, MART-1, gp100 and tyrosinase will be administered emulsified in Incomplete Freund's Adjuvant, (IFA) to HLA-A201 patients with melanoma. The study is designed to evaluate the potential therapeutic role, immunologic effects and toxicity of repeated doses of this peptide vaccine administered subcutaneously.
Immune reactivity to the peptide epitope will be monitored in all patients by analysis of melanoma-specific T cell precursors prior to and after immunization.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Any patient 16 years of age or older with measurable metastatic melanoma who has failed standard treatment and has an expected survival of greater than three months.
Must be HLA-A0201.
Serum creatinine of 2.0 mg/dl or less.
Bilirubin 1.6 mg/dl or less.
WBC 3000/mm(3) or greater.
Platelet count 90,000 mm(3) or greater.
Serum AST/ALT less then two times normal.
ECOG performance status of 0 or 1.
Patients of both genders must be willing to practice effective birth control during the trial.
Must not be undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their cancer.
Must not have active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease.
Must not require steroid therapy.
Must not be pregnant.
Must not be positive for hepatitis B(s)AG or HIV antibody.
Must not have had a known allergic reaction to Incomplete Freund's Adjuvant (IFA).
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00001685 History of Changes |
| Other Study ID Numbers: | 980023, 98-C-0023 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| Health Authority: | United States: Federal Government |
|
Cancer IL-12 IL-2 Immunotherapy Vaccine |
|
Neoplasms Melanoma Neoplasm Metastasis Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Neoplastic Processes Pathologic Processes |
