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Immunization of Patients with Metastatic Melanoma Using DNA Encoding the GP100 Melanoma Antigen



Immunization of Patients with Metastatic Melanoma Using DNA Encoding the GP100 Melanoma Antigen

For Condition: Melanoma,Neoplasm Metastasis
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a study of a melanoma tumor antigen DNA vaccine. Plasmid DNA encoding the T cell antigen gp100 will be administered to patients with metastatic melanoma. Patients will receive DNA injections every 4 weeks for up to 4 doses. The study is designed to evaluate the potential therapeutic role, immunologic effects and toxicity of repeated doses of this DNA vaccine administered either alone or in conjunction with the cytokine adjuvant, IL-2. Immune reactivity to the DNA vaccine will be monitored in all patients by analysis of melanoma-specific T cell precursors prior to and after immunization.
Details: This is a study of a melanoma tumor antigen DNA vaccine. Plasmid DNA encoding the T cell antigen gp100 will be administered to patients with metastatic melanoma. Patients will receive DNA injections every 4 weeks for up to 4 doses. The study is designed to evaluate the potential therapeutic role, immunologic effects and toxicity of repeated doses of this DNA vaccine administered either alone or in conjunction with the cytokine adjuvant, IL-2. Immune reactivity to the DNA vaccine will be monitored in all patients by analysis of melanoma-specific T cell precursors prior to and after immunization.
Eligibility:
Study Type:  Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Any patient age greater than or equal to 16 with measurable metastatic melanoma who has failed standard treatment and has an expected survival of greater than three months will be considered. 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 than two times normal; ECOG performance status of 0 or 1. Patients of both genders must be willing to practice effective birth control during this trial. EXCLUSION CRITERIA: Patients will be excluded: Who are undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their cancer; Have active systemic infections, coagulation disorders, autoimmune disease or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease; Who require steroid therapy; Who are pregnant; Who are known to be positive for hepatitis BsAG or HIV antibody; Who have any form of primary or secondary immunodeficiency.
Total Enrollment: 65

Location and Contact Information:

National Cancer Institute (NCI)
Bethesda,  Maryland,  20892
United States
 


Additional Information:
Study ID Numbers:  980086;  98-C-0086
Study Start Date: March 28, 1998
Record last reviewed: July 8, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001692

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