Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT00003450|
Recruitment Status : Completed
First Posted : December 5, 2003
Last Update Posted : February 2, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Peritoneal Cavity Cancer||Biological: Ad5CMV-p53 gene||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Trial of Intraperitoneal Adenoviral p53 Gene Therapy in Patients With Advanced Recurrent or Persistent Ovarian Cancer|
|Study Start Date :||September 1998|
|Actual Primary Completion Date :||January 1999|
|Actual Study Completion Date :||January 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003450
|United States, Texas|
|Simmons Cancer Center - Dallas|
|Dallas, Texas, United States, 75235-9154|
|Study Chair:||Carolyn Y. Muller, MD||University of New Mexico Cancer Center|