Clinical trial · Interventional
Gene Therapy in Treating Patients With Ovarian Cancer
A Phase I Study of Ad-p53 (NSC# 683550) for Patients With Platinum- and Paclitaxel-Resistant Epithelial Ovarian Cancer
NCT00003588CI-TRIAL-00009377completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ad5CMV-p53 gene | Biological | — | UNRESOLVED |
| laparoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Biological: Ad5CMV-p53 gene
- Procedure: laparoscopic surgery
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.