Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients - Full Text View

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:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

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:

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

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

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

National Cancer Institute (NCI)

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
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female

Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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