NCT02046174

Open-Label Phase IIb Efficacy Trial of Cancer Macrobeads Compared to Best Supportive Care in Colorectal Cancer Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: The Rogosin Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical research study of an investigational (FDA IND-BB 10091) treatment for patients with 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 description

This is a Phase IIb, multicenter, nonrandomized, open-label study with RENCA macrobeads in patients with treatment-resistant, metastatic colorectal carcinoma to determine the effect of RENCA macrobead implantation on overall survival compared with best supportive care. Two treatment groups will be enrolled in this study, as follows: * Group A (n=40) - patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight * Group B (n=80) - patients who had previously decided (independently of this study) to receive, or continue receiving, best supportive care, defined as management of symptoms aimed at maintaining or improving quality of life, but not including approved therapies targeting the patient's malignancy

Conditions

• Colorectal Cancers

Interventions

Type	Name	Description
BIOLOGICAL	RENCA macrobeads

Timeline

• Start date: 2014-04-03
• Primary completion: 2018-10-22
• Completion: 2018-10-22
• First posted: 2014-01-27
• Last updated: 2021-03-24
• Results posted: 2021-03-24

Locations

4 sites across 1 country: United States