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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003588 |
RATIONALE: 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.
PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients with ovarian cancer that has not responded to previous treatment.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: Ad5CMV-p53 gene Procedure: laparoscopic surgery |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Ad-p53 (NSC# 683550) for Patients With Platinum- and Paclitaxel-Resistant Epithelial Ovarian Cancer |
Study Start Date: | September 1998 |
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.
PROJECTED ACCRUAL: Approximately 15-30 patients will be accrued in this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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 Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL PT/PTT normal Renal: Creatinine no greater than 1.4 mg/dL Pulmonary: No active, unresolved upper respiratory infections Other: 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: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics May have failed an unlimited number of prior chemotherapy regimens At least 30 days since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the pelvis or abdomen Surgery: Eligible for laparoscopy
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Chair: | Judith K. Wolf, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000066657, MDA-ID-97228, NCI-T97-0111 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003588 |
Health Authority: | United States: Federal Government |
stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Ovarian epithelial cancer Recurrence Genital Diseases, Female Paclitaxel Endocrinopathy Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |