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

Primary Purpose

Ovarian Cancer, Primary Peritoneal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tenckhoff Catheter placement
Ad5-delta24RGD
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian cancer study

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • UAB Highlands, 1201 11th Ave S, 4th Floor, Gynecologic Oncology

Outcomes

Primary Outcome Measures

To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD

Secondary Outcome Measures

To determine biologic, immunologic, and anti-tumor effects of Ad5-delta24RGD

Full Information

First Posted
November 20, 2007
Last Updated
January 25, 2011
Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00562003
Brief Title
Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients
Acronym
Ad5Delta24RGD
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Primary Peritoneal Cancer
Keywords
Ovarian cancer study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Tenckhoff Catheter placement
Intervention Description
'Tenckhoff catheter' will be placed into the abdominal cavity by a minor surgical procedure performed in the Radiology Department.
Intervention Type
Drug
Intervention Name(s)
Ad5-delta24RGD
Intervention Description
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'.
Primary Outcome Measure Information:
Title
To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD
Time Frame
1 month
Secondary Outcome Measure Information:
Title
To determine biologic, immunologic, and anti-tumor effects of Ad5-delta24RGD
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: WBC> 3,000 ul Granulocytes> 1,500 ul Platelets> 100,000 Creatinine clearance (actual or calculated) >80 mg/dl or serum creatinine <2.0 Serum transaminases <2.5x upper limits of normal Normal serum bilirubin PT/PTT/INR < 1.5 x institutional ULN Ejection fraction on echocardiogram > 55% 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald D Alvarez, M.D.
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Highlands, 1201 11th Ave S, 4th Floor, Gynecologic Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients

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