NCT00089206已完成2 期
Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
详细描述
OBJECTIVES:
- Determine the antitumor immune response in patients with unresectable stage III or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51.
OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response.
PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of melanoma
- •Unresectable stage III or IV disease
- •Mucosal or ocular disease allowed
- •Positive HLA-A1, -A2, or -A3 expression
- •PATIENT CHARACTERISTICS:
- •12 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
- •Weight ≥ 100 pounds
- •Not pregnant or nursing
- •No other malignancy within the past 5 years except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior vaccination with any of the peptides used in this protocol
- •More than 1 year since prior melanoma vaccine therapy
- •More than 4 weeks since prior immunotherapy
- •More than 4 weeks since prior growth factors
- •More than 4 weeks since prior allergy shots
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy
- •Endocrine therapy
- •More than 4 weeks since prior steroid therapy
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy
- •Prior tumor resection allowed
排除标准
- 未提供
研究者
Craig L Slingluff, Jr
Professor of Surgery
University of Virginia
研究点 (1)
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