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Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic/Colorectal Cancer

NCT01053013 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-05-12

Study results available
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Summary

This is a clinical research study of an investigational (FDA BB-IND 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.

Conditions

  • Pancreatic Adenocarcinoma Non-resectable
  • Pancreatic Adenocarcinoma Metastatic
  • Colorectal Cancer Metastatic

Interventions

BIOLOGICAL

RENCA macrobeads

Sponsors & Collaborators

  • Vital Systems Inc.

    collaborator OTHER

  • The Rogosin Institute

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-15
Primary Completion
2016-04-16
Completion
2016-04-16

Countries

  • United States

Study Locations

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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 NCT01053013 on ClinicalTrials.gov