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A Phase I Study of gp100 Human Melanoma Peptide Vaccine with Incomplete Freund's Adjuvant



A Phase I Study of gp100 Human Melanoma Peptide Vaccine with Incomplete Freund's Adjuvant

For Condition: Melanoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a phase I study of melanoma tumor antigen peptide vaccines. The nine amino acid peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen, gp100 will be administered to patients emulsified in Incomplete Freund's Adjuvant, (IFA). The study is designed to evaluate the toxicity, immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously. Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization.
Details: This is a phase I study of melanoma tumor antigen peptide vaccines. The nine amino acid peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen, gp100 will be administered to patients emulsified in Incomplete Freund's Adjuvant, (IFA). The study is designed to evaluate the toxicity, immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously. Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization.
Eligibility:
Study Type:  Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Metastatic melanoma that is HLA-A2 positive. No primary melanoma of ocular or mucosal origin. Measurable or resected metastatic disease required. PRIOR/CONCURRENT THERAPY: BIOLOGIC THERAPY: No prior (greater than 30 days) or concurrent Biologic Therapy. CHEMOTHERAPY: No prior (greater than 30 days) or concurrent chemotherapy. ENDOCRINE THERAPY: No prior (greater than 30 days) or concurrent hormone therapy. No requirement for steroids. RADIOTHERAPY: No prior (greater than 30 days) or concurrent radiotherapy. SURGERY: Not specified. PATIENT CHARACTERISTICS: Age: 18 and over. Performance Status: ECOG 0 or 1. Life Expectancy: More than 3 months. HEMATOPOIETIC: No coagulation disorder. HEPATIC: Bilirubin no greater than 2.0 mg/dL. No Hepatitis BsAg antibody. RENAL: Creatinine no greater than 2.0 mg/dL. CARDIOVASCULAR: No major cardiovascular illness. PULMONARY: No major respiratory illness. OTHER: No previous allergic reaction to incomplete Freund's adjuvant. HIV negative. No active systemic infection. Not pregnant or lactating.
Total Enrollment: 255

Location and Contact Information:

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


Additional Information:
Study ID Numbers:  950145;  95-C-0145
Study Start Date: June 18, 1995
Record last reviewed: May 1, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001439

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3. Immunotherapy with Autologous Dexosomes for Patients with Stage IV Melanoma

4. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver

5. Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma

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