A Phase 2 interventional study of Immunodominant peptides from three melanoma antigens, MART-1, GP100 and tyrosinase in Melanoma and Neoplasm Metastasis, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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.
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.
3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.
This study's enrollment of 114 is above the median of 38 across 2,400 interventional studies indexed under Melanoma.
Browse Melanoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.
Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
The record gives a start of Nov 1997 and a completion of Sep 2000. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 1999. You cannot join it, but the record below documents what was studied.
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