Pilot Study of DRibble Vaccine for Prostate Cancer Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

October 24, 2014

Primary Completion Date

August 15, 2018

Study Completion Date

August 15, 2018

Conditions
Adenocarcinoma of the Prostate
Interventions
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.

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.

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.

Trial Locations (1)

97213

Providence Health & Services, Portland

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Providence Health & Services

OTHER

collaborator

Providence Cancer Center

UNKNOWN

collaborator

Providence Cancer Center, Earle A. Chiles Research Institute

OTHER

lead

UbiVac

INDUSTRY

NCT02234921 - Pilot Study of DRibble Vaccine for Prostate Cancer Patients | Biotech Hunter | Biotech Hunter