Gene Therapy in Treating Patients With Ovarian Cancer
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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