Phase I Trial of Intraperitoneal Adenoviral p53 Gene Therapy in Patients With Advanced Recurrent or Persistent Ovarian Cancer
OBJECTIVES: I. Determine the maximum tolerated dose and toxicities of intraperitoneal
adenoviral p53 gene therapy in patients with advanced, recurrent, or persistent ovarian
carcinoma. II. Evaluate the vector pharmacokinetics and biologic efficacy of gene transfer,
gene expression, and cell death in these patients. III. Determine the immunologic response
to therapy in these patients.
OUTLINE: This is a dose escalation study of adenoviral p53 gene therapy. Patients undergo
removal of ascites, if present, from the peritoneal cavity followed by a bolus infusion of
adenovirus p53 once a week for 3 consecutive weeks, followed by a 2 week rest. Treatment
continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients who experience palliative results with at least stable disease may continue
treatment weekly without the rest period. Cohorts of 3-6 patients are treated at each level
of adenovirus p53. The maximum tolerated dose is defined as the dose level below that at
which 2 of 6 patients experience dose limiting toxicity. Patients who receive the MTD
without unacceptable toxicity may continue to receive treatment on a weekly basis.
PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued over 16-18 months for this
Primary Purpose: Treatment
Carolyn Y. Muller, MD
University of New Mexico Cancer Center
United States: Federal Government
|Simmons Cancer Center - Dallas||Dallas, Texas 75235-9154|