Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver Metastases
|ClinicalTrials.gov Identifier: NCT00107861|
Recruitment Status : Completed
First Posted : April 12, 2005
Last Update Posted : July 14, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Carcinoma Metastases||Drug: Ad.hIFN-β (BG00001, IDEC-201)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2005|
|Actual Study Completion Date :||September 2006|
- - 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107861
|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|