Gene Therapy in Treating Patients With Ovarian Cancer

Plain-language summary

This study examined a gene therapy (Ad5CMV-p53 gene) together with laparoscopic surgery in patients with ovarian cancer. Patients aged 18 and over with recurrent or progressing ovarian epithelial cancer resistant to platinum and paclitaxel could take part. The study was carried out in Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

National Cancer Institute (NCI)

Intervention

Ad5CMV-p53 gene, laparoscopic surgery

Start date

9/1/1998

Countries

United States

Related genes

Locations

• Houston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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