A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Life Expectancy: More than 3 months.
- •HEMATOPOIETIC: No coagulation disorder.
- •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.
- •No previous allergic reaction to incomplete Freund's adjuvant.
- •HIV negative.
- •No active systemic infection.
- •Not pregnant or lactating.
排除标准
- 未提供