Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic or Colorectal Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/11/2019 |
| Start Date: | February 2010 |
| End Date: | December 2020 |
| Contact: | Barry H Smith, MD, PhD |
| Email: | bas2005@nyp.org |
| Phone: | 212-746-1551 |
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 Treatment-Resistant, Metastatic Pancreatic or Colorectal Adenocarcinoma
This is a clinical research study of an investigational (FDA IND-BB 10091) treatment for
patients with pancreatic cancer (all stages) and advanced colorectal cancer that no longer
responds to standard therapies.
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.
patients with pancreatic cancer (all stages) and advanced colorectal cancer that no longer
responds to standard therapies.
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 pancreas, colon or rectum
- Evidence of metastasis
- Failed available therapies (pancreatic cancer may be treated without previous
therapies)
- Resolution of any toxic effects of previous therapies
- Performance status (ECOG PS) 0-2
- Adequate hematologic, coagulation (INR 2-3 max), hepatic and renal function
- Life expectancy of at least 6 weeks
- For females, a negative pregnancy test
- Agrees to contraceptive use while on study if sexually active
- Informed consent
Exclusion Criteria:
- Any condition presenting an unacceptably high anesthetic or surgical risk
- HIV positive
- Cognitive impairment such as to preclude informed consent
- Surgical treatment or chemotherapy within three weeks of scheduled macrobead
implantation or within four weeks of bevacizumab (or similar drugs), or radiation
therapy within four weeks of scheduled macrobead implantation
- 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
We found this trial at
1
site
413 East 69th Street
New York, New York 10021
New York, New York 10021
Principal Investigator: Thomas J. Fahey, M.D.
Phone: 212-746-9233
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