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Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients

NCT00562003 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2011-01-26

No results posted yet for this study

Summary

The primary purpose of this study is to determine the maximally tolerated dose and spectrum of toxicities encountered with intraperitoneal delivery of a RGD modified conditionally replicative adenovirus (Ad5-Delta 24RGD) in patients with recurrent ovarian cancer.

Secondary objectives :

* To determine the biologic effects encountered with intraperitoneal delivery of Ad5-Delta 24RGD in patients with recurrent ovarian cancer cells
* To determine immunologic response generated against Ad5-Delta 24RGD when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma
* To determine potential clinical activity of Ad5-Delta 24RGD when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma

Conditions

Interventions

PROCEDURE

Tenckhoff Catheter placement

'Tenckhoff catheter' will be placed into the abdominal cavity by a minor surgical procedure performed in the Radiology Department.

DRUG

Ad5-delta24RGD

Within two weeks before the start of the study, a physical exam, blood tests, removal of fluid from abdominal cavity through the catheter and a CT scan of abdomen and pelvis will be performed. The procedure will involve receiving the Ad5-delta24RGD virus once a day for 3 days. The virus will be put into the abdominal cavity through a 'Tenckhoff catheter'.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Ronald D Alvarez, M.D. · The University of Alabama at Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-05-31
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00562003 on ClinicalTrials.gov