Pilot Study of DRibble Vaccine for Prostate Cancer Patients
- Conditions
- Adenocarcinoma of the Prostate
- Interventions
- Registration Number
- NCT02234921
- Lead Sponsor
- UbiVac
- Brief Summary
This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 3
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DRibble Vaccine Cyclophosphamide 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). DRibble Vaccine 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). DRibble Vaccine HPV Vaccinations 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). DRibble Vaccine Imiquimod 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).
- Primary Outcome Measures
Name Time Method Safety Assessment 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.
- Secondary Outcome Measures
Name Time Method Immune Response 28 weeks Patients will have 11 blood draws during the study to evaluate the immune response. In addition, patients will undergo two leukapheresis procedures and provide two biopsy samples (if cancer is amenable to safe biopsy) to evaluate immune response.
Prostate Cancer Response to DRibble vaccine 28 weeks Patients will have 8 Prostate-Specific Antigen (PSA) Tests over a 22-week period and 3 CT scans over a 28-week period to assess response to treatment.
Trial Locations
- Locations (1)
Providence Health & Services
🇺🇸Portland, Oregon, United States