Clinical Trial: Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic or Colorectal Cancer
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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 Treatme
Brief Summary:
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.
Detailed Summary:
Sponsor: The Rogosin Institute
Current Primary Outcome: Tumor volume and number of metastases [ Time Frame: 16 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Progression-free survival [ Time Frame: 16 months ]
Original Secondary Outcome: Same as current
Information By: The Rogosin Institute
Dates:
Date Received: January 20, 2010
Date Started: February 2010
Date Completion: December 2018
Last Updated: May 3, 2017
Last Verified: May 2017