Phase I Study of Percutaneous Injections of Adeno-Virus p53 Construct (ADENO-p53) for Hepatocellular Carcinoma
I. Determine the safety of adenovirus p53 construct (adeno-p53) in patients with
II. Investigate the potential effects of intralesional adeno-p53 given by monthly
percutaneous injections in these patients.
OUTLINE: This is a dose escalation, multicenter study.
Patients receive adenovirus p53 construct by percutaneous injection to a maximum of two
lesions on day 1. Treatment is repeated every 28 days for up to 6 courses. In the absence of
dose-limiting toxicity (DLT) in the first cohort of 6 patients treated, subsequent cohorts
of 6 patients each receive escalating doses of the drug on the same schedule. If DLT occurs
in 2 of 6 patients at a given dose level, then dose escalation ceases and that dose is
declared the maximum tolerated dose. Study treatment may continue in the absence of disease
progression and unacceptable adverse events.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Chandra P. Belani, MD
University of Pittsburgh
United States: Food and Drug Administration
|Albert Einstein Comprehensive Cancer Center||Bronx, New York 10461|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|