Gene Therapy in Treating Patients With Ovarian Cancer

NCT ID: NCT00003588

Last Updated: 2013-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-09-30

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

Ad5CMV-p53 gene

Intervention Type: BIOLOGICAL

laparoscopic surgery

Intervention Type: PROCEDURE

Interventions

Ad5CMV-p53 gene

Intervention Type: BIOLOGICAL

laparoscopic surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith K. Wolf, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

MDA-ID-97228

Identifier Type: -

Identifier Source: secondary_id

NCI-T97-0111

Identifier Type: -

Identifier Source: secondary_id

CDR0000066657

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02277

Identifier Type: -

Identifier Source: org_study_id