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

October 9, 2018 updated by: UbiVac

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Health & Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Cyclophosphamide
A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.
Other Names:
  • Cytoxan
Biological: DRibble Vaccine
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.
Other Names:
  • DPV-001 DRibble vaccine
Biological: HPV Vaccinations
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.
Other Names:
  • Ceravix
Drug: Imiquimod
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Assessment
Time Frame: 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.
28 Weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome identification
Time Frame: 12 weeks
Patients will provide 3 stool samples for microbiome identification for future research to see if there is a correlation with response to treatment.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UbiVac

Collaborators

Providence Health & Services
Providence Cancer Center, Earle A. Chiles Research Institute
Providence Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2014

Primary Completion (Actual)

August 15, 2018

Study Completion (Actual)

August 15, 2018

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 4, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-116B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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