Clinical Trials Directory

Trials / Completed

CompletedNCT00107861

Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver Metastases

A Phase I/II Study of Interferon-Beta Gene Transfer (Ad.hIFN-β) in the Treatment of Refractory Colorectal Carcinoma With Liver Metastases

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
44 (planned)
Sponsor
Biogen · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study will be conducted in subjects with refractory colorectal carcinoma with unresectable liver metastases. The purposes of the study are: * to evaluate the safety and any harmful effects of an intravenous injection of Ad.hIFN-β; * help determine whether the virus carrying the interferon-beta gene will enter the bloodstream and liver tumor cells and cause the cancer cells to die.

Detailed description

This trial is a clinical research study of Ad.hIFN-β, an investigational, replication-defective, recombinant adenovirus containing the human interferon beta gene, for people that have refractory colorectal carcinoma with liver metastases. Scientists have been exploring a variety of approaches to develop medications to treat patients with refractory colorectal carcinoma with liver metastases; a disease for which current treatment provides only limited relief, so there is a need for new medications.

Conditions

Interventions

TypeNameDescription
DRUGAd.hIFN-β (BG00001, IDEC-201)

Timeline

Start date
2005-05-01
Completion
2006-09-01
First posted
2005-04-12
Last updated
2009-07-14

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00107861. Inclusion in this directory is not an endorsement.