A Phase 2 Study of Prostate Specific Antigen Peptide 3A (PSA: 154-163(155L) ) (NSC # 722932, IND#9787) With Montanide ISA-51(NSC #675756, IND #9787) or Montanide® ISA 51 VG (NSC 737063) Vaccination in Prostate Cancer Recurrent
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in frequency of CD8 T-lymphocyte precursors in peripheral blood mononuclear cells (PBMC), measured by ELISPOT assays
研究概览
简要总结
This phase II trial is studying how well vaccine therapy works in treating patients with recurrent prostate cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells
详细描述
PRIMARY OBJECTIVES:
I. Determine the T-lymphocyte immune response in patients with recurrent adenocarcinoma of the prostate treated with prostate-specific antigen (PSA) peptide vaccine (PSA-3A; PSA: 154-163 [155L]) emulsified in Montanide ISA-51.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this vaccine in these patients. II. Determine the effect of this vaccine on serum PSA level in these patients.
OUTLINE: This is a pilot 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate
- •Must have undergone radical prostatectomy ≥ 3 months ago
- •Prostate-specific antigen (PSA) level ≥ 0.6 ng/mL and rising (after radical prostatectomy) on ≥ 2 measurements separated by ≥ 3 months
- •HLA-A2-positive peripheral blood mononuclear cells by flow cytometry
- •No clinical evidence of local recurrence
- •No palpable induration or mass in prostatic fossa
- •No metastatic prostate cancer
- •No osseous metastases by bone scan
- •Performance status - ECOG 0-1
- •Performance status - Karnofsky 70-100%
- •More than 1 year
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Bilirubin normal
- •Hepatitis B and C negative
- •Creatinine normal
- •Creatinine clearance ≥ 60 mL/min
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study PSA peptide vaccine or Montanide ISA-51
- •No history of systemic autoimmune disease or autoimmune disease requiring anti-inflammatory or immunosuppressive therapy
- •Patients with history of autoimmune thyroiditis are eligible provided the patient requires only thyroid hormone replacement therapy AND disease has been stable for ≥ 1 year
- •No known HIV positivity
- •No ongoing or active infection
- •No primary or secondary immune deficiency
- •No psychiatric illness or social situation that would preclude study compliance
- •No history of other uncontrolled illness
- •No prior chemotherapy
- •No prior hormonal therapy
- •No concurrent systemic or ocular steroid therapy, except for any of the following:
- •Inhaled steroids for asthma
- •Limited topical steroids
- •Replacement doses of cortisone
- •More than 4 weeks since prior radiotherapy
- •No prior radiotherapy to the prostate
- •Prior radiotherapy to the pelvis after radical prostatectomy allowed
- •See Disease Characteristics
- •No other concurrent investigational agents
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Change in frequency of CD8 T-lymphocyte precursors in peripheral blood mononuclear cells (PBMC), measured by ELISPOT assays
时间窗: From baseline to 1 week after the last dose of study treatment
A response is defined as at least a 5 fold higher frequency of INF-gamma secreting CD8 T cells after vaccination than before. A patient also will be considered a responder if no specific PSA: 154-163(155L) response was found before vaccination and a specific PSA: 154-163(155L) response is identified after vaccination.
次要结局
- Effect of treatment on serum prostate-specific antigen level(Up to 4 weeks after completion of study treatment)
- Incidence of adverse events graded according to NCI CTCAE version 3.0(Up to 4 weeks after completion of study treatment)