Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver Metastases
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.
Drug: Ad.hIFN-β (BG00001, IDEC-201)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Interferon-Beta Gene Transfer (Ad.hIFN-β) in the Treatment of Refractory Colorectal Carcinoma With Liver Metastases|
- - Evaluate the safety of a single IV administration of Ad.hIFN-β.
- Evaluate the MTD or maximum feasible dose (MFD) of Ad.hIFN-β.
- Evaluate IFN-β and Ad.hIFN-β vector serum concentrations.
- Evaluate immunogenicity of Ad.hIFN-β by measuring human anti adenovirus and human anti-IFN-β antibody formation.
- Explore preliminary clinical activity.
|Study Start Date:||May 2005|
|Study Completion Date:||September 2006|
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.
|United States, California|
|University of California San Diego|
|La Jolla, California, United States, 92037|
|United States, Texas|
|Mary Crowley Medical Research Center|
|Dallas, Texas, United States, 75201|