A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating DCVax(tm)-Prostate, Autologous Dendritic Cells Loaded With Recombinant PSMA for the Treatment of Metastatic Hormone Refractory Prostate Cancer
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Northwest Biotherapeutics
- Locations
- 16
- Status
- Withdrawn
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate.
Detailed Description
Patients with hormone refractory prostate cancer are eligible if they have a rising PSA or three or fewer metastatic lesions. The experimental therapy uses a patient's own white blood cells and "teaches" the cells to recognize a "flag" on prostate cancer cells. This may help the immune system destroy prostate cancer cells. Side effects reported from the Phase I/II trial include skin reactions of redness, pain \& swelling at the injection site, and short-lived headache, fever \& fatigue. Full details are available in the informed consent.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified