search
Back to results

Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer

Primary Purpose

Ovarian Cancer, Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ad5CMV-p53 gene
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, peritoneal cavity cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed invasive ovarian epithelial carcinoma or primary peritoneal carcinoma at time of initial laparotomy No histologically confirmed noninvasive ovarian malignancy or low malignant potential tumor or carcinomatosis from other nonovarian or peritoneal sites At least three courses of first-line combination chemotherapy (platinum and paclitaxel) with either persistent or recurrent disease If no treatment with first-line paclitaxel, salvage paclitaxel failure must be documented prior to eligibility Ascites that is cytologically positive for adenocarcinoma or gross evidence of recurrent disease with ascites, or gross recurrent disease with abdominopelvic washing cytologically positive for adenocarcinoma Adequate peritoneal distribution by Technetium 99 scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2.5 times normal No active hepatitis or chronic liver failure Renal: Creatinine no greater than 2 mg/dL Other: Not HIV positive No concurrent immunosuppressive disorders No active systemic infections or active peritonitis Geographically available for follow-up Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: No prior viral based gene therapy treatments or p53 directed vaccines No other prior gene therapy Chemotherapy: See Disease Characteristics At least 4 weeks since chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since surgery, including surgery for a perforated bowel, bowel anastamosis, colostomy, or ileostomy

Sites / Locations

  • Simmons Cancer Center - Dallas

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
January 29, 2021
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00003450
Brief Title
Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer
Official Title
Phase I Trial of Intraperitoneal Adenoviral p53 Gene Therapy in Patients With Advanced Recurrent or Persistent Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
January 1999 (Actual)
Study Completion Date
January 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Peritoneal Cavity Cancer
Keywords
stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, peritoneal cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Ad5CMV-p53 gene

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed invasive ovarian epithelial carcinoma or primary peritoneal carcinoma at time of initial laparotomy No histologically confirmed noninvasive ovarian malignancy or low malignant potential tumor or carcinomatosis from other nonovarian or peritoneal sites At least three courses of first-line combination chemotherapy (platinum and paclitaxel) with either persistent or recurrent disease If no treatment with first-line paclitaxel, salvage paclitaxel failure must be documented prior to eligibility Ascites that is cytologically positive for adenocarcinoma or gross evidence of recurrent disease with ascites, or gross recurrent disease with abdominopelvic washing cytologically positive for adenocarcinoma Adequate peritoneal distribution by Technetium 99 scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2.5 times normal No active hepatitis or chronic liver failure Renal: Creatinine no greater than 2 mg/dL Other: Not HIV positive No concurrent immunosuppressive disorders No active systemic infections or active peritonitis Geographically available for follow-up Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: No prior viral based gene therapy treatments or p53 directed vaccines No other prior gene therapy Chemotherapy: See Disease Characteristics At least 4 weeks since chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since surgery, including surgery for a perforated bowel, bowel anastamosis, colostomy, or ileostomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Y. Muller, MD
Organizational Affiliation
University of New Mexico Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Simmons Cancer Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9154
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer

We'll reach out to this number within 24 hrs