Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00562003
First received: November 20, 2007
Last updated: January 25, 2011
Last verified: January 2011
  Purpose

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

Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Cancer
Procedure: Tenckhoff Catheter placement
Drug: Ad5-delta24RGD
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine biologic, immunologic, and anti-tumor effects of Ad5-delta24RGD [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: June 2007
Study Completion Date: June 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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'.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

    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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562003

Locations
United States, Alabama
UAB Highlands, 1201 11th Ave S, 4th Floor, Gynecologic Oncology
Birmingham, Alabama, United States, 35205
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Ronald D Alvarez, M.D. The University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Ronald D. Alvarez, MD / Director,Division of Gynecologic Oncology, UAB
ClinicalTrials.gov Identifier: NCT00562003     History of Changes
Other Study ID Numbers: F061005016 (UAB 0643), UAB 0643
Study First Received: November 20, 2007
Last Updated: January 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:
Ovarian cancer study

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014