Status:
COMPLETED
Pilot Study of DRibble Vaccine for Prostate Cancer Patients
Lead Sponsor:
UbiVac
Collaborating Sponsors:
Providence Health & Services
Providence Cancer Center
Conditions:
Adenocarcinoma of the Prostate
Eligibility:
MALE
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 24 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2018
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02234921
Start Date
October 24 2014
End Date
August 15 2018
Last Update
October 11 2018
Active Locations (1)
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1
Providence Health & Services
Portland, Oregon, United States, 97213