Immunization of HLA-A201 Patients With Metastatic Melanoma Using a Combination of Immunodominant Peptides From Three Melanoma Antigens, MART-1, GP100 and Tyrosinase
Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002
Trial Information
Current as of May 09, 2025
Completed
Keywords
ClinConnect Summary
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 ...
Gender
ALL
Eligibility criteria
- • 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).
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bethesda, Maryland, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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