3
Participants
Start Date
October 24, 2014
Primary Completion Date
August 15, 2018
Study Completion Date
August 15, 2018
Cyclophosphamide
A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.
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.
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.
Providence Health & Services, Portland
Lead Sponsor
Providence Health & Services
OTHER
Providence Cancer Center
UNKNOWN
Providence Cancer Center, Earle A. Chiles Research Institute
OTHER
UbiVac
INDUSTRY