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Gene Therapy in Treating Patients With Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ad5CMV-p53 gene
laparoscopic surgery
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed metastatic ovarian epithelial cancer that is platinum- and paclitaxel resistant as defined by: Disease progression while on first-line regimen containing both a platinum drug and paclitaxel OR Tumor progression within 6 months of completion of platinum-based therapy (either as first- or second-line) or paclitaxel-based therapy (either as first- or second-line) Refractory or recurrent ovarian epithelial cancer as defined by: Lesions of any diameter Nonmeasurable disease (with CA-125 at least 35) Ascites and/or pleural effusions allowed No borderline or low malignant potential tumors PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Bilirubin no greater than 1.5 mg/dL PT/PTT normal Creatinine no greater than 1.4 mg/dL No active, unresolved upper respiratory infections Not HIV positive At least 5 years since prior malignancy, except nonmelanomatous skin cancer Willing and able to undergo placement of Tenckhoff catheter in the peritoneal cavity for sampling of ascites or peritoneal fluid No concurrent serious medical illness No untreated gastrointestinal obstruction Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: May have failed an unlimited number of prior chemotherapy regimens At least 30 days since prior chemotherapy No prior radiotherapy to the pelvis or abdomen Eligible for laparoscopy

Sites / Locations

  • University of Texas - MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

Patients undergo laparoscopy for p53 assessment and catheter placement. Patients receive daily intraperitoneal injections of adenovirus p53 (Ad-p53) for 5 days every 3 weeks. Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each are treated at each dose level of Ad-p53. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 7, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003588
Brief Title
Gene Therapy in Treating Patients With Ovarian Cancer
Official Title
A Phase I Study of Ad-p53 (NSC# 683550) for Patients With Platinum- and Paclitaxel-Resistant Epithelial Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2002
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase I trial to study the effectiveness of gene therapy in treating patients with ovarian cancer that has not responded to previous treatment. Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer or make the cancer cells more sensitive to treatment.
Detailed Description
OBJECTIVES: I. Determine the maximum tolerated doses of adenovirus p53 in patients with platinum- and paclitaxel-resistant ovarian epithelial cancer. II. Determine the qualitative and quantitative toxic effects of this regimen in these patients. III. Document the observed anti-tumor activity of this regimen in these patients. IV. Evaluate the biological endpoints (e.g., induction of apoptosis, p53 expression) of this regimen in these patients. OUTLINE: This is a dose escalation study. Patients undergo laparoscopy for p53 assessment and catheter placement. Patients receive daily intraperitoneal injections of adenovirus p53 (Ad-p53) for 5 days every 3 weeks. Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each are treated at each dose level of Ad-p53. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients undergo laparoscopy for p53 assessment and catheter placement. Patients receive daily intraperitoneal injections of adenovirus p53 (Ad-p53) for 5 days every 3 weeks. Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each are treated at each dose level of Ad-p53. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity.
Intervention Type
Biological
Intervention Name(s)
Ad5CMV-p53 gene
Intervention Type
Procedure
Intervention Name(s)
laparoscopic surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic ovarian epithelial cancer that is platinum- and paclitaxel resistant as defined by: Disease progression while on first-line regimen containing both a platinum drug and paclitaxel OR Tumor progression within 6 months of completion of platinum-based therapy (either as first- or second-line) or paclitaxel-based therapy (either as first- or second-line) Refractory or recurrent ovarian epithelial cancer as defined by: Lesions of any diameter Nonmeasurable disease (with CA-125 at least 35) Ascites and/or pleural effusions allowed No borderline or low malignant potential tumors PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Bilirubin no greater than 1.5 mg/dL PT/PTT normal Creatinine no greater than 1.4 mg/dL No active, unresolved upper respiratory infections Not HIV positive At least 5 years since prior malignancy, except nonmelanomatous skin cancer Willing and able to undergo placement of Tenckhoff catheter in the peritoneal cavity for sampling of ascites or peritoneal fluid No concurrent serious medical illness No untreated gastrointestinal obstruction Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: May have failed an unlimited number of prior chemotherapy regimens At least 30 days since prior chemotherapy No prior radiotherapy to the pelvis or abdomen Eligible for laparoscopy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith K. Wolf, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Gene Therapy in Treating Patients With Ovarian Cancer

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