A Phase I Study in Patients With Peritoneal Carcinomatosis Using SCH 58500 (rAd/p53) Administered by Single Intraperitoneal Instillation
OBJECTIVES: I. Assess the safety of SCH-58500 (recombinant adenoviral vector containing p53
tumor suppressor gene) when given as a single or multiple intraperitoneal instillation in
combination with chemotherapy to patients with peritoneal carcinomatosis demonstrating p53
mutant ovarian, fallopian tube, or peritoneal carcinoma. II. Assess the biological activity
of SCH-58500 by confirming wild type p53 gene expression. III. Assess the stability of
SCH-58500 infection and expression by collection and analysis of serial, posttreatment,
ascites specimens in a subset of 5 patients. IV. Assess the pharmacokinetics of SCH-58500 by
serum and peritoneal fluid measurements. V. Document any clinical evidence of antitumor
activity in these patients treated with this regimen.
OUTLINE: This is an abbreviated dose escalation, multicenter study of SCH-58500. Patients
receive SCH-58500 by intraperitoneal instillation on days 1-5 (depending on dose level).
Patients undergo ascites fluid and tumor sampling before and after intraperitoneal
instillation. The ascitic fluid or tumor and normal tissue are then submitted for cytologic
or histopathologic examination and biological activity analysis. Cohorts of 3-6 patients
receive escalating doses of SCH-58500 until 3 patients experience dose limiting toxicity or
until the highest planned dose is reached. Patients are followed at 2 months, every 3 months
for 1 year, and then yearly thereafter.
PROJECTED ACCRUAL: A total of 6-60 patients will be accrued for this study.
Primary Purpose: Treatment
Jo Ann Horowitz, MD
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|