Vaccination With Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells in Patients With Advanced Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Immunogenicity
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.
详细描述
OBJECTIVES:
- Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF).
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43.
- Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
- Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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:
- •Diagnosis of stage IIIB, IIIC, or IV melanoma
- •HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive
- •Brain metastases allowed at the discretion of the principle investigator
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,000/mm^3
- •Platelet count > 100,000/mm ^3
- •Hemoglobin > 9 g/dL
- •Liver function tests ≤ 2.5 times upper limit of normal (ULN)
- •Creatinine ≤ 1.5 times ULN
- •Cardiovascular
- •No New York Heart Association class III or IV heart disease
- •Prior diagnosis of other cancer allowed
- •Not pregnant or nursing
- •Weight ≥ 110 pounds
- •No uncontrolled diabetes
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior growth factors
- •More than 4 weeks since prior allergy shots
- •More than 12 weeks since prior melanoma vaccine therapy* NOTE: *Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine
- •No prior vaccination with any of the peptides used in this study
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy
- •Endocrine therapy
- •More than 4 weeks since prior steroids
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy
- •Not specified
- •More than 1 month since prior investigational drugs or therapies
- •No other concurrent investigational drugs or therapies
排除标准
- 未提供
研究组 & 干预措施
Arm A. 6MHP vaccine 200 mcg
vaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
干预措施: IFA (Biological)
Arm A. 6MHP vaccine 200 mcg
vaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
干预措施: 6MHP (Biological)
Arm B. 6MHP vaccine 400 mcg
vaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
干预措施: IFA (Biological)
Arm B. 6MHP vaccine 400 mcg
vaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
干预措施: 6MHP (Biological)
Arm C. 6MHP vaccine 800 mcg
vaccine containing 6 melanoma helper peptides, at 800 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
干预措施: IFA (Biological)
Arm C. 6MHP vaccine 800 mcg
vaccine containing 6 melanoma helper peptides, at 800 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
干预措施: 6MHP (Biological)
Arm C. 6MHP vaccine 800 mcg
vaccine containing 6 melanoma helper peptides, at 800 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
干预措施: GM-CSF (Biological)
Arm B. 6MHP vaccine 400 mcg
vaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
干预措施: GM-CSF (Biological)
Arm A. 6MHP vaccine 200 mcg
vaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
干预措施: GM-CSF (Biological)
结局指标
主要结局
Immunogenicity
时间窗: day 22
Melanoma peptide-specific helper T cell responses in the sentinel immunized node (SIN) on day 22.
Safety: Dose-limiting toxicity
时间窗: During study period
Toxicities measured by CTCAE.
次要结局
- Immune response in the blood(day 50)
- DTH response(by day 85)
- Clinical outcome(during the study)
研究者
Craig L Slingluff, Jr
Professor of Surgery
University of Virginia