Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Ad5CMV-p53 gene

+ laparoscopic surgery

BiologicalProcedure
Who is being recruted

Urogenital Diseases+16

+ Genital Diseases

+ Adnexal Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 1998
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: February 8, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00003588
Principal SponsorNational Cancer Institute (NCI)
Last updated: February 8, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesCarcinomaEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOvarian DiseasesUrogenital NeoplasmsFemale Urogenital DiseasesCarcinoma, Ovarian EpithelialOvarian Neoplasms

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group 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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Texas - MD Anderson Cancer Center

Houston, United StatesOpen University of Texas - MD Anderson Cancer Center in Google Maps
CompletedOne Study Center