CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
RENCA macrobeadsbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01053013
NCT01053013Phase 2Completed

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 Treatment-Resistant, Metastatic Pancreatic or Colorectal Cancer

The Rogosin Institute·interventional·Posted Jan 21, 2010·Updated May 12, 2021

In Brief

A Phase 2 clinical trial evaluating RENCA macrobeads for Pancreatic Adenocarcinoma Non-resectable and 2 related conditions. Completed, enrolled 58 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsVital Systems Inc.

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 21, 2010
Enrollment StartApr 15, 2010
Primary CompletionApr 16, 2016
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 16.4 years ago

Interventions

RENCA macrobeadsbiological