Pilot Study of DRibble Vaccine for Prostate Cancer Patients

Study Overview
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Brief Summary
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This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.

Detailed Description
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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.

Official Title
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A Pilot Study of DPV-001 DRibble Vaccine With Imiquimod in Advanced Prostate Cancer

Conditions
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Adenocarcinoma of the Prostate

Intervention / Treatment
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* Drug: Cyclophosphamide
* Biological: DRibble Vaccine
* Biological: HPV Vaccinations
* Drug: Imiquimod


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DRibble Vaccine<br>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). | Drug: Cyclophosphamide<br>* A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.<br>* Other names: Cytoxan;Biological: DRibble Vaccine<br>* DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19 and 22. Eight vaccinations will be administered. Week 1 and 4 vaccines will be administered by intranodal injections performed using ultrasound guidance.<br>* Other names: DPV-001 DRibble vaccine;Biological: HPV Vaccinations<br>* Patients will receive a dose of 0.5-mL CERVARIX at week 1 (Day 4) and week 7 by intramuscular injection at a site distant from the DRibble vaccine.<br>* Other names: Ceravix;Drug: Imiquimod<br>* Imiquimod cream (5%, 250 mg) will be self-applied topically for 5 consecutive days by patients to a 4 x 5-cm outlined area of healthy extremity skin starting on the day of the second vaccine and again during each additional vaccine cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | 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. | 28 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune Response | 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. | 28 weeks | 
| Prostate Cancer Response to DRibble vaccine | 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. | 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, Adenocarcinoma, Metastatic, DRibble, Immunotherapy, Microbiome