Gene Therapy in Treating Patients With Ovarian Cancer

National Cancer Institute (NCI)30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

Ad5CMV-p53 geneBIOLOGICAL

laparoscopic surgeryPROCEDURE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Data from ClinicalTrials.gov

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