NCT00616291已完成1 期
Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Tolerability
研究概览
简要总结
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects of a peptide vaccine in treating patients with metastatic prostate cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the safety and tolerance of NY-ESO-1/LAGE-1 class-I and class-II vaccine administered subcutaneously in patients with androgen-independent metastatic prostate cancer.
Secondary
- Compare the response induced by immunotherapy with a combined class-I and class-II NY-ESO-1/LAGE-1 vaccine to responses obtained to either class I or class II peptides alone.
- Evaluate whether the inclusion of class-II epitopes in a peptide vaccine will result in a better antitumor immune response than class-I epitopes alone.
- Determine antitumor activity by antigen response assays including cytokine elaboration, changes in frequency of peripheral T cells that recognize tumor, and intra/peritumoral cellular infiltrates and cytokine expression in responding and nonresponding metastasis.
研究设计
- 研究类型
- Interventional
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Tolerability
Toxicity
次要结局
- Immunological response
研究者
Teresa Hayes
Associate Professor
Baylor College of Medicine
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma MultiformeMalignant Neoplasms of BrainNCT00643097John Sampson40
终止
2 期
Vaccine Therapy, Paclitaxel, and Carboplatin in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube CancerFallopian Tube CancerPrimary Peritoneal Cavity CancerOvarian CancerNCT00373217Craig L Slingluff, Jr6
Unknown
3 期
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in RemissionLeukemiaNCT00454168The Vaccine Company244
已完成
早期 1 期
Vaccine Therapy in Treating Patients With Previously Treated Stage II or Stage III Breast CancerBreast CancerNCT00640861Mayo Clinic45
终止
早期 1 期
Vaccine Therapy in Treating Patients With Stage IIB, Stage III, or Stage IV Colorectal CancerColorectal CancerNCT00091286Craig L Slingluff, Jr11
