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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed prostate cancer with evidence of progressive disease despite hormonal therapy (i.e., hormone-refractory prostate cancer)
- •Metastatic disease
- •Progressive disease defined by any of the following:
- •New bone lesion on bone scan
- •Progression of nodal or soft tissue as evidenced by standard radiographic methods, i.e., CT scan or MRI
- •A 50% increase in PSA level from the nadir PSA level confirmed twice and measured at least 2 weeks apart, with stable and measurable disease
- •Castrate serum levels of testosterone < 50 ng/dL
- •If patient was receiving anti-androgen therapy, in addition to luteinizing hormone-releasing hormone (LHRH) agonist therapy, the evidence of progressive disease should persist after a trial of anti-androgen withdrawal
- •Treatment with LHRH agonist to maintain androgen ablation must continue throughout this trial
- •Baseline PSA ≥ 10 ng/mL
- •All patients with androgen-independent prostate cancer and matched HLA typing are eligible for vaccination regardless of initial NY-ESO-1 expression status
- •Patients must be typed for HLA-DR4, DR13, DP4, or HLA-A2 haplotypes
- •No active brain metastases
- •PATIENT CHARACTERISTICS:
- •Zubrod performance status 0-2
- •Life expectancy ≥ 12 weeks
- •ANC ≥ 1,500/mm³
- •Hemoglobin ≥ 10 mg/dL
- •Platelet count ≥ 100,000/mm³
- •Bilirubin ≤ 1.5 mg/dL
- •SGPT ≤ 3 times upper limit of normal
- •Serum creatinine ≤ 2 mg/dL
- •Wiling to be followed at Baylor College of Medicine
- •No serious intercurrent medical illness
- •No history of primary or secondary immunodeficiency
- •No active systemic infection
- •No known hepatitis B surface antigen, hepatitis C, or HIV antibody positivity
- •No history of cardiac arrhythmia or ischemic heart disease
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 6 weeks since prior immunotherapy (including anti-androgen therapy) and recovered
- •More than 28 days since prior chemotherapy
- •No concurrent immunosuppressive drugs such as systemic corticosteroids
排除标准
- 未提供
研究组 & 干预措施
Group I
Experimental
MHC Class I binding peptide at 1000 mcg
干预措施: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine (Biological)
Group II
Experimental
MHC Class II binding peptide at 1000 mcg
干预措施: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine (Biological)
Group III
Experimental
Combination MHC Class I and II binding peptide at 1000 mcg each
干预措施: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine (Biological)
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 (1)
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