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

NCT02046174 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-03-24

Study results available
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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

Conditions

Interventions

BIOLOGICAL

RENCA macrobeads

Sponsors & Collaborators

  • Vital Systems Inc.

    collaborator OTHER

  • The Rogosin Institute

    lead OTHER

Principal Investigators

  • Thomas J Fahey, III., M.D. · Weill Cornell Medical Center / New York-Presbyterian Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-03
Primary Completion
2018-10-22
Completion
2018-10-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02046174 on ClinicalTrials.gov