Pilot Trial of Multi-Epitope Melanoma Peptide Vaccine Using GM-CSF, Montanide and QS-21 as Adjuvants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Vaccines made from peptides that are found on melanoma cells may make the body build an immune response and kill melanoma cells. Combining vaccine therapy with immune adjuvants, such as GM-CSF, Montanide ISA-51, or QS21, may be a more effective treatment for advanced melanoma.
PURPOSE: Randomized phase II trial to study the effectiveness of gp 100-tyrosinase peptide vaccine with one of the immune adjuvants GM-CSF, Montanide ISA-51, or QS21 in treating patients who have stage III or stage IV melanoma.
详细描述
OBJECTIVES: I. Evaluate the immunogenicity of gp100-tyrosinase peptide vaccine with sargramostim (GM-CSF), Montanide ISA-51, or QS21 as adjuvant in patients with advanced melanoma. II. Determine the toxicity of this multiepitope melanoma peptide vaccine in conjunction with these 3 adjuvants in these patients. III. Evaluate the antitumor effects of this multiepitope melanoma peptide vaccine in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to age (65 years and under vs more than 65 years) and previous systemic chemotherapy (yes vs no). Patients are randomized to 1 of 3 treatment arms: Arm I (Sargramostim (GM-CSF) as adjuvant): Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine administered intradermally during weeks 1, 5, and 9. For each vaccination, GM-CSF is administered intradermally on days 1-10; the vaccine is administered on day 7. Arm II (Montanide ISA-51): Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine mixed with Montanide ISA-51 and administered subcutaneously (SQ) during weeks 1, 5, and 9. Arm III (QS21 as adjuvant): Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine mixed with QS21 and administered SQ during weeks 1, 5, and 9. Patients with stable or responding disease may receive 3 additional monthly immunizations beginning 3-6 months following completion of 1 course of immunizations if there is evidence of T cell response against either wild type peptide. Patients are followed at weeks 13 and 17.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 18-24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS: Histologically confirmed unresectable stage III or stage IV melanoma Patients who are disease free following surgical resection or chemotherapy for stage III or IV disease also eligible HLA-A201 positive
- •PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 5 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 75,000/mm3 LDH no greater than 2 times upper limit of normal No active bleeding Hepatic: Albumin at least 3.5 mg/dL Renal: Not specified Other: Not pregnant or less than 3 months postpartum Fertile patients must use effective contraception No serious underlying medical conditions No known immunodeficiency No active infection No retinal or choroidal eye disease
- •PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No prior tyrosinase or gp100 peptides No prior Montanide ISA-51 No prior melanoma protein vaccine or melanoma whole cell vaccines No other concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior systemic steroids and recovered No concurrent systemic steroids Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to the spleen No concurrent radiotherapy Surgery: Recovered from any prior surgery No prior splenectomy Other: At least 1 week since prior antiinflammatory drugs and recovered At least 1 week since prior antihistamines and recovered No concurrent antiinflammatory drugs No concurrent antihistamines No concurrent antimicrobial drugs
排除标准
- 未提供