Pilot Study of DRibble Vaccine for Prostate Cancer Patients (DRibble)
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|ClinicalTrials.gov Identifier: NCT02234921|
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : October 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate||Drug: Cyclophosphamide Biological: DRibble Vaccine Biological: HPV Vaccinations Drug: Imiquimod||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of DPV-001 DRibble Vaccine With Imiquimod in Advanced Prostate Cancer|
|Actual Study Start Date :||October 24, 2014|
|Actual Primary Completion Date :||August 15, 2018|
|Actual Study Completion Date :||August 15, 2018|
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).
A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.
Other Name: 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 Name: 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 Name: Ceravix
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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234921
|United States, Oregon|
|Providence Health & Services|
|Portland, Oregon, United States, 97213|
|Principal Investigator:||Brendan Curti, MD||Providence Health & Services|