Last updated on November 2017

An Open-Label, Phase II Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Cell-Containing Agarose-Agarose Macrobeads in the Treatment of Patients with Treatment-Resistant, Metastatic Pancreatic Adenocarcinoma or Colorectal Cancer


Brief description of study

An Open-Label, Phase II Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Cell-Containing Agarose-Agarose Macrobeads in the Treatment of Patients with Treatment-Resistant, Metastatic Pancreatic Adenocarcinoma or Colorectal Cancer

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 pancreatic or treatment resistant colorectal cancers.

Potential candidates for this study are males or females, 18 years or older, with a minimum life expectancy of 6 weeks. Medical conditions indicating that the surgical implantation of the beads would involve an unacceptably high risk for the individual would not be eligible to participate.

The study is divided into a maximum of 4 implantations of beads, starting every 3 months, with regular follow-up visits between implantations and after the fourth 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. Regardless of the number of implantations, subjects will be followed-up by the study team throughout their lifetime.

Clinical Study Identifier: TX6994

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Thomas Fahey, M.D.

The Rogosin Institute
New York, NY USA
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