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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

Other Melanoma Studies:
1. Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma

2. gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma

3. Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity

4. Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201

5. A Phase III Multi-Institutional Randomized Study of Immunization with the gp100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients with Metastatic Melanoma

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