Adenocarcinoma of the Prostate
Conditions
Keywords
Prostate, Adenocarcinoma, Metastatic, DRibble, Immunotherapy, Microbiome
Brief summary
This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.
Detailed 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.
Interventions
DRUGCyclophosphamide
A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.
BIOLOGICALDRibble 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.
BIOLOGICALHPV 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.
DRUGImiquimod
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.
Sponsors
Providence Health & Services
Providence Cancer Center
Providence Cancer Center, Earle A. Chiles Research Institute
UbiVac
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment | 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
| Measure | Time frame | Description |
|---|---|---|
| Immune Response | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Microbiome identification | 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. |
Countries
United States
Outcome results
None listed