Immunization of HLA-A201 Patients With Metastatic Melanoma Using a Combination of Immunodominant Peptides From Three Melanoma Antigens, MART-1, GP100 and Tyrosinase
Data Collection
Melanoma+13
+ Neoplasm Metastasis
+ Neoplasms
Treatment Study
Summary
Study start date: November 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.114 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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).
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Cancer Institute (NCI)
Bethesda, United StatesOpen National Cancer Institute (NCI) in Google Maps