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Pilot Study of DRibble Vaccine for Prostate Cancer Patients (DRibble)

Primary Purpose

Adenocarcinoma of the Prostate

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cyclophosphamide
DRibble Vaccine
HPV Vaccinations
Imiquimod
Sponsored by
UbiVac
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate focused on measuring Prostate, Adenocarcinoma, Metastatic, DRibble, Immunotherapy, Microbiome

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.

Sites / Locations

  • Providence Health & Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DRibble Vaccine

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 4, 2014
Last Updated
October 9, 2018
Sponsor
UbiVac
Collaborators
Providence Health & Services, Providence Cancer Center, Providence Cancer Center, Earle A. Chiles Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02234921
Brief Title
Pilot Study of DRibble Vaccine for Prostate Cancer Patients
Acronym
DRibble
Official Title
A Pilot Study of DPV-001 DRibble Vaccine With Imiquimod in Advanced Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 24, 2014 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
August 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UbiVac
Collaborators
Providence Health & Services, Providence Cancer Center, Providence Cancer Center, Earle A. Chiles Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate
Keywords
Prostate, Adenocarcinoma, Metastatic, DRibble, Immunotherapy, Microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DRibble Vaccine
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.
Intervention Type
Biological
Intervention Name(s)
DRibble Vaccine
Other Intervention Name(s)
DPV-001 DRibble vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
HPV Vaccinations
Other Intervention Name(s)
Ceravix
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety Assessment
Description
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.
Time Frame
28 Weeks
Secondary Outcome Measure Information:
Title
Immune Response
Description
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.
Time Frame
28 weeks
Title
Prostate Cancer Response to DRibble vaccine
Description
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.
Time Frame
28 weeks
Other Pre-specified Outcome Measures:
Title
Microbiome identification
Description
Patients will provide 3 stool samples for microbiome identification for future research to see if there is a correlation with response to treatment.
Time Frame
12 weeks

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brendan Curti, MD
Organizational Affiliation
Providence Health & Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Health & Services
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://oregon.providence.org/our-services/p/providence-cancer-center/
Description
Providence Cancer Center

Learn more about this trial

Pilot Study of DRibble Vaccine for Prostate Cancer Patients

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