Last updated on March 2014

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


Brief description of study

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

Detailed Study Description

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.

Clinical Study Identifier: TX137964

Contact Investigators or Research Sites near you

Start Over

Thomas Fahey, M.D.

The Rogosin Institute
New York, NY USA
  Connect »