Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients (Ad5Delta24RGD)

January 25, 2011 updated by: University of Alabama at Birmingham

A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (Ad5-Delta 24 RGD)for Intraperitoneal Delivery in Ovarian and Extraovarian Cancer Patients (Infectivity Enhanced Virotherapy for Ovarian Cancer)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35205
    - UAB Highlands, 1201 11th Ave S, 4th Floor, Gynecologic Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Patients must have histologically documented invasive epithelial ovarian or extra-ovarian adenocarcinoma
Patients must have persistent or recurrent disease after standard debulking/staging surgery and conventional chemotherapy.Prior chemotherapy must have included a taxane/platinum based regimen
Patients must have evidence of intraabdominal disease; disease may be measurable or nonmeasurable
Patients must have a GOG performance status of 0, 1, or 2, and have a life expectancy of greater than 3 months
Patients must have adequate hematologic, renal, cardiac, pulmonary, coagulation, and hepatic function defined as:
1. WBC> 3,000 ul
2. Granulocytes> 1,500 ul
3. Platelets> 100,000
4. Creatinine clearance (actual or calculated) >80 mg/dl or serum creatinine <2.0
5. Serum transaminases <2.5x upper limits of normal
6. Normal serum bilirubin
7. PT/PTT/INR < 1.5 x institutional ULN
8. Ejection fraction on echocardiogram > 55%
9. O2 saturation > 92%
Patients must be 19 years or older (as mandated by Alabama state law) and must have signed informed consent

Exclusion Criteria:

Patients with epithelial ovarian tumors of low malignant potential (with or without invasive implants), with ovarian stromal tumors, or with germ cell tumors of the ovary are ineligible to participate in the study
Patients with the only site of disease located beyond the abdominal cavity are ineligible to participate in the study
Patients who are pregnant or lactating are ineligible to participate in the study
Patients with a GOG performance status of 3 or 4 are ineligible to participate in the study
Patients with active heart disease (characterized by angina, unstable arrhythmia, congestive heart failure or EF < 55%, pulmonary hypertension), active or chronic debilitating pulmonary disease (i.e., active pneumonia, severe COPD, pulmonary edema, O2 saturation < 92%), or coagulation disorders (i.e., bleeding disorders, on therapeutic anti-coagulants)

Study Plan

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

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD Time Frame: 1 month	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine biologic, immunologic, and anti-tumor effects of Ad5-delta24RGD Time Frame: 1 month	1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Ronald D Alvarez, M.D., The University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria