Current as of November 28, 2023
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 ...
- 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 National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States
All reviews come from applied patients