Status:
COMPLETED
Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Macrobeads in Subjects With Castration-Resistant Prostate Cancer Resistant to Taxanes (Docetaxel, Cabazitaxel) and Evidence of Disease Progression on Androgen-axis Inhibition and/or Immunotherapy in the Form of Sipuleucel-T
Lead Sponsor:
The Rogosin Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This is a clinical research study of an investigational (FDA IND-BB 10091) treatment of subjects with castration-resistant prostate cancer resistant to Taxanes (docetaxel, cabazitaxel) and evidence of...
Eligibility Criteria
Inclusion
- Cancer of prostate
- Evidence of metastasis
- Failed available therapies
- Resolution of any toxic effects of previous therapies
- Performance status (ECOG PS) 0-2
- Adequate hematologic, coagulation (INR 2-3max), hepatic and renal function
- Life expectancy of 12 months
- Agrees to contraceptive use while on study if sexually active
- Sign informed consent document
Exclusion
- Any condition presenting an unacceptably high anesthetic or surgical risk
- HIV positive
- Cognitive impairment such as to preclude informed consent
- Other surgical treatment, chemotherapy and radiation within four weeks of baseline
- Inadequate hematologic, coagulation (INR \>3), hepatic, renal function
- Hepatic blood flow abnormalities and/or large-volume ascites
- Concurrent cancer of any other type except skin cancer (excluding melanoma)
- History of allergic reactions to mouse antigens
- Active infection, congestive heart failure, unstable angina, serious cardiac arrhythmias, psychiatric illness, difficult social situations not permitting reliable participation, active bleeding
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01174368
Start Date
June 1 2010
End Date
April 1 2017
Last Update
January 16 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Rogosin Institute
New York, New York, United States, 10021