Pilot Study of DRibble Vaccine for Prostate Cancer Patients

Adenocarcinoma of the Prostate Clinical Trial

— DRibble  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234921
• Other study ID #: 14-116B
• Status: Completed
• Phase: Phase 1
• Start date: October 24, 2014
• Est. completion date: August 15, 2018

Study information

• Verified date: October 2018
• Source: UbiVac
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms

Intervention

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

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.
• 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.

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.

Locations

Country	Name	City	State
United States	Providence Health & Services	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
UbiVac	Providence Cancer Center, Providence Cancer Center, Earle A. Chiles Research Institute, Providence Health & Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microbiome identification	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
Primary	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	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
Secondary	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

External Links

•   Providence Cancer Center