Houston, Texas 77030

  • Ovarian Cancer


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.

Study summary:

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.


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



Primary Contact:

Study Chair
Judith K. Wolf, MD
M.D. Anderson Cancer Center

Backup Contact:


Location Contact:

Houston, Texas 77030
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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