Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT00003450
Brief Summary:
RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of gene therapy using the p53 gene in treating patients with advanced recurrent or persistent ovarian cancer or primary peritoneal cavity cancer.
Detailed Description:
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 study.
Study:
NCT00003450
Study Brief:
Protocol Section:
NCT00003450