Colorectal cancer that no longer responds to standard therapies

Protocol Title
A Phase IIb, Nonrandomized, Open-Label Trial with Mouse Renal Adenocarcinoma (RENCA) Cell Containing Agarose-Agarose Macrobeads Compared with Best Supportive Care in Patients with Treatment-Resistant, Metastatic Colorectal Carcinoma

Principal Investigator & Contact Information
Thomas J. Fahey, M.D.
Phone: (212) 746-5130

Study Status

Brief Summary of Protocol
This phase II study is evaluating the safety (health risks and side effects) and efficacy of The Rogosin Institute’s investigational [not approved by the Food and Drug Administration (FDA)] macrobeads. The macrobeads are small-sugarcoated beads containing cancer cells from a mouse kidney cancer cell line and are surgically implanted in the abdominal cavity of patients with treatment resistant colorectal cancer.  The study will consist of two groups; those who will have macrobead implantation(s) and those who have decided independently of this study not to pursue therapeutic treatment of their cancer (best supportive care). Potential candidates are males or females, 18 years or older, with treatment resistant, metastatic colorectal cancer with a minimum life expectancy of 6 weeks at the time disease progression is documented.

For patients receiving implantations, the study is divided into a maximum of 4 implantations of macrobeads, at least 3 months apart, with regular follow-up visits between implantations and after the final implantation. The study involves a screening phase, the surgical implantation(s) of the macrobeads, repeat blood and urine work, follow-up clinical visits and regular imaging studies. Individuals with medical conditions indicating that the surgical implantation of the beads would involve an unacceptably high risk for the individual are not eligible to participate. Regardless of the number of implantations, subjects will be followed-up by the study team throughout their lifetime.

Patients receiving best supportive care will not have any assessments performed as part of this study. Their participation will consist of permission to review their medical records and record relevant medical information, agreement to be followed for survival, and review of entry criteria. Patients will not be randomly assigned to either treatment group or best supportive care group; the decision to try any investigational treatment or not to remains with the patient independently of this research study.

Treatment Overview (Potential Benefits)
There is no guarantee that participants will receive direct benefit from this study. Participation in this study may add knowledge about the macrobeads that may one day help others with cancer.

Study Sponsor
The Rogosin Institute
505 East 70th Street
New York, NY 10021

IRB Information
Weill Cornell Medical College IRB
1300 York Avenue, Box 89
New York, NY 10065
Protocol # 1310014396
ClinicalTrials.gov Identifier:  NCT02046174