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
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/18/2019 |
| Start Date: | June 2010 |
| End Date: | April 2017 |
An Open-Label, Phase II Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Cell-Containing Agarose-Agarose Macrobeads in the Treatment of 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
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 disease progression on androgen-axis inhibition and/or
immunotherapy in the form of sipuleucel-T.
The treatment is being evaluated for its effect on tumor growth. It consists of the placement
(implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA
macrobeads). The cells in the macrobeads produce substances that have been shown to slow or
stop the growth of tumors in experimental animals and veterinary patients. It has been tested
in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II
studies in patients with colorectal, pancreatic or prostate cancers are in progress.
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.
The treatment is being evaluated for its effect on tumor growth. It consists of the placement
(implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA
macrobeads). The cells in the macrobeads produce substances that have been shown to slow or
stop the growth of tumors in experimental animals and veterinary patients. It has been tested
in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II
studies in patients with colorectal, pancreatic or prostate cancers are in progress.
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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