Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver Metastases
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|