Gene Therapy in Treating Patients With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

A Phase I Study of Ad-p53 (NSC# 683550) for Patients With Platinum- and Paclitaxel-Resistant Epithelial Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003588
• Other study ID #: NCI-2012-02277
• Secondary ID: MDA-ID-97228NCI-
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: February 7, 2013
• Start date: September 1998

Study information

• Verified date: June 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Biological:
• Ad5CMV-p53 gene

Procedure:
• laparoscopic surgery

Locations

Country	Name	City	State
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,