Pilot Trial to Investigate Immune Response to an Extended Course of Sipuleucel-T Immunotherapy in Patients With Metastatic Castration-resistant Prostate Cancer (OU-SCC-EXCITE)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Proportion of patients completing 3 doses of Sipuleucel-T immunotherapy.
研究概览
简要总结
Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).
详细描述
This open-label, pilot trial aims to evaluate the feasibility of Sipuleucel-T given in three doses at weeks 0, 2, and 12-14; and to investigate the changes in immune response in mCRPC patients who are getting an extended course of Sipuleucel-T treatment.
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
- •Men ≥ 18 years of age
- •Prostate cancer with history of metastasis
- •Candidates for Sipuleucel-T treatment are defined as those with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy of ≥ 6 months
排除标准
- •Previously received Sipuleucel-T (Provenge®)
- •Known malignancies other than prostate cancer likely to require treatment within 6 months following registration
- •A requirement for systemic immunosuppressive therapy (>10mg Prednisone daily or equivalent)
- •A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF
- •Any infection requiring antibiotic therapy within 1 week prior to registration
研究组 & 干预措施
Extended course of Sipuleucel-T treatment
干预措施: Sipuleucel-T (Biological)
结局指标
主要结局
Proportion of patients completing 3 doses of Sipuleucel-T immunotherapy.
时间窗: up to 5 months
Patients will be treated with Sipuleucel-T immunotherapy and the treatment regimen will be considered feasible if 85% of enrolled patients complete all three infusions of Sipuleucel-T treatment given at week 0, 2 and 12-14.
Proportion of subjects who have detectable elevated IgG level and/or T-cell proliferation from baseline to the follow-up of extended course of Sipuleucel-T immunotherapy.
时间窗: up to 12 Months
For patients undergoing Sipuleucel-T treatment on weeks 0, 2 and 12-14, the changes in immune response will be measured based on the detectable elevated levels of IgG and/or T-cell proliferation against various types of prostate cancer associated antigens at baseline, and at Sipuleucel-T infusion doses given at week 0, 2 and 12-14 weeks.
次要结局
- Evaluate the potential tumor response based on the changes in serum PSA at baseline and within 30 days of last dose.(up to 12 Months)
- Evaluate the mean difference in immune response to Sipuleucel-T treatment among different racial groups.(up to 12 months)