Phase I Dose Escalation Trial of CP-675,206 (Tremelimumab, Anti-CTLA-4 Monoclonal Antibody) in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The Number of Participants Who Developed Cancer Antigen-specific Immune Responses
研究概览
简要总结
The current protocol will evaluate the safety of combining treatment with bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with PSA-recurrent non-metastatic (stage D0) prostate cancer. This is a dose escalation study with safety the primary endpoint. Secondary endpoints will be to determine whether prostate associated immune responses are seen, and whether treatment is associated with an increase in PSA doubling time and PSA recurrence at one year, as markers of clinical activity. Cohorts of six patients will be treated in each dose level. The investigators hypothesize that short-term androgen deprivation therapy will elicit prostate cancer-associated T-cell mediated tissue destruction that can be augmented with a monoclonal antibody blocking CTLA-4, and that this will have therapeutic benefit in patients with recurrent prostate cancer.
详细描述
This is an open label, single-center Phase I study. All subjects will receive bicalutamide 150mg orally days 1-28. Subjects will receive CP-675,206 IV over one hour on day 29. Doses will range from 6 mg/kg to 15 mg/kg. This cycle will be repeated once at month 3. Once the maximum tolerated dose has been determined, up to 6 additional subjects will be enrolled.
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
- •At least 18 years of age & histologic diagnosis of adenocarcinoma of the prostate
- •Completed surgery or radiation at least 8 weeks prior to entry with removal of all visible disease
- •Clinical Stage D0 prostate cancer with rising PSA and PSA >2ng/ml.
- •ECOG performance of <2
- •Normal hematologic, renal and liver function
排除标准
- •Cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy.
- •No prior treatment with an LHRH agonist or nonsteroidal antiandrogen such as casodex or flutamide
- •No evidence for metastatic disease per bone scan or CT scan of the abdomen and pelvis
- •No prior treatment with anti-CTLA 4 monoclonal antibody
- •No history of known autoimmune disorder or HIV, hepatitis B or hepatitis C
- •No known brain metastases
- •No history of inflammatory bowel conditions including diverticulitis, ulcerative colitis, etc.
研究组 & 干预措施
1
Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
干预措施: Bicalutamide and CP-675,206 (Tremelimumab) (Drug)
1
Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
干预措施: Bicalutamide, CP-675,206 (Tremelimumab) (Drug)
1
Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
干预措施: Bicalutamide, CP-675,206 (Drug)
结局指标
主要结局
The Number of Participants Who Developed Cancer Antigen-specific Immune Responses
时间窗: Up to 12 months after treatment with study agent
次要结局
- The Number of Participants With an Increase in PSA Doubling Time(Up to 18 months after last dose of study agent)
- Number of Participants With PSA Recurrence.(one year)