NCT00003588

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2002

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

August 26, 2004

Completed
Last Updated

February 8, 2013

Status Verified

June 1, 2002

Enrollment Period

3.5 years

First QC Date

November 1, 1999

Last Update Submit

February 7, 2013

Conditions

Ovarian Cancer

Keywords

stage IV ovarian epithelial cancerrecurrent ovarian epithelial cancer

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Biological: Ad5CMV-p53 geneProcedure: laparoscopic surgery

Interventions

Ad5CMV-p53 geneBIOLOGICAL
Arm I
laparoscopic surgeryPROCEDURE
Arm I

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

advexinLaparoscopy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Judith K. Wolf, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 26, 2004

Study Start

September 1, 1998

Primary Completion

March 1, 2002

Last Updated

February 8, 2013

Record last verified: 2002-06

Locations

US(1)