A Pilot Study of DPV-001 DRibble Vaccine With Imiquimod in Advanced Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Safety Assessment
研究概览
简要总结
This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.
详细描述
The primary objective of this pilot study is to assess the safety and tolerability of DRibble vaccine, cyclophosphamide, imiquimod, and Ceravix in castrate resistant prostate cancer.
This study will also assess:
- the immune profile of tumor biopsy specimens if sites amenable to biopsy are present
- humoral and cellular responses to cancer antigens after DRibble vaccination
- the response to a reporter antigen vaccine (Ceravix) after DRibble vaccination
An exploratory objective is to characterize the microbiome before and after study drugs administration and correlate prostate cancer responses.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects have measurable or evaluable metastatic castrate resistant adenocarcinoma of the prostate with progression after chemotherapy, combined androgen blockade and/or peripheral androgen or androgen receptor suppression. Either histologic or serum marker diagnosis is acceptable.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Ability to give informed consent and comply with the protocol.
- •Prior therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment.
- •Patients must have normal organ and marrow function as determined by routine blood tests
排除标准
- •Active autoimmune disease except vitiligo or hypothyroidism.
- •Active other malignancy.
- •Known HIV positive and/or Hepatitis B or C positive.
- •Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.
研究组 & 干预措施
DRibble Vaccine
Patients will receive cyclophosphamide 3 days prior to the first of 9 planned DRibble vaccine injections. Imiquimod will be applied following 6 injections. Patients will receive 2 HPV vaccinations (Human papillomavirus).
干预措施: Cyclophosphamide (Drug)
DRibble Vaccine
Patients will receive cyclophosphamide 3 days prior to the first of 9 planned DRibble vaccine injections. Imiquimod will be applied following 6 injections. Patients will receive 2 HPV vaccinations (Human papillomavirus).
干预措施: DRibble Vaccine (Biological)
DRibble Vaccine
Patients will receive cyclophosphamide 3 days prior to the first of 9 planned DRibble vaccine injections. Imiquimod will be applied following 6 injections. Patients will receive 2 HPV vaccinations (Human papillomavirus).
干预措施: HPV Vaccinations (Biological)
DRibble Vaccine
Patients will receive cyclophosphamide 3 days prior to the first of 9 planned DRibble vaccine injections. Imiquimod will be applied following 6 injections. Patients will receive 2 HPV vaccinations (Human papillomavirus).
干预措施: Imiquimod (Drug)
结局指标
主要结局
Safety Assessment
时间窗: 28 Weeks
Patients will come to clinic 10 times over a 28 week period and have blood tests and vital sign measurements at each visit. In addition, patients will have 8 physical exams and performance status evaluations during this time period to evaluate possible toxicities related to study treatment.
次要结局
- Immune Response(28 weeks)
- Prostate Cancer Response to DRibble vaccine(28 weeks)