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Completed

NCT Number: NCT02234921

Pilot Study of DRibble Vaccine for Prostate Cancer Patients

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

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Key information

Conditions

Adenocarcinoma of the Prostate Adenocarcinoma Carcinoma Mouth Diseases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Salivary Gland Diseases Sialorrhea Stomatognathic Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Providence Health & Services

Portland, Oregon, 97213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cyclophosphamide

Drug

A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.

Other names: Cytoxan

DRibble vaccine

Biological

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

HPV Vaccinations

Biological

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

Imiquimod

Drug

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

UbiVac

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: DRibble

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2014
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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