An Open-Label, Phase 2 Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Cell-Containing Agarose- Agarose Macrobeads in the Treatment of Patients With Castration-Resistant Prostate Cancer Resistant to Docetaxel
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10021 |
| Conditions: |
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Prostate Cancer |
| Purpose: |
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This is a clinical research study of an investigational (FDA IND-BB 10091) treatment of
subjects with castration-resistant prostate cancer resistant to docetaxel.
The treatment is being evaluated for its effect on tumor growth. It consists of small beads
that contain mouse cancer cells from a mouse kidney cancer cell line. The cells in the beads
produce substances that have shown to slow or stop the growth of tumors in experimental
animals, veterinary patients, and 23 human subjects with different types of cancers in a
Phase I safety trial.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- 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 Criteria:
- 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
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| NCT ID: |
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NCT01174368 |
| Primary Contact: |
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Principal Investigator
Barry H Smith, MD
The Rogosin Institute
Barry H Smith, MD
Phone: 212 746 1551
Email: bas2005@nyp.org
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| Backup Contact: |
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Email: nab2009@nyp.org
Nathaniel Berman, MD
Phone: 212-746-9766
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| Location Contact: |
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New York, New York 10021
United States
Barry H Smith, MD
Phone: 212-746-1551
Email: bas2005@nyp.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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