This protocol describes the first human trial of a systemically delivered gene therapy product for treatment of cancer. The primary aim of the trial is to define the pharmacokinetics and toxicity of the product when delivered into hepatic artery. Patients will be monitored on the GCRC for signs of toxicity as well as to identify any excretion of adenovirus that may occur. The efficiency and stability of gene transfection will be studied in detail to determine anti-tumor effect, impact of provoked immunologic response & cellular and molecular effects of expression of wild type p53 in the transduced tumor cells over a range of doses.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000079-36S1
Application #
6115222
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
36
Fiscal Year
1999
Total Cost
Indirect Cost
Name
University of California San Francisco
Department
Type
DUNS #
073133571
City
San Francisco
State
CA
Country
United States
Zip Code
94143
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