Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients

Ovarian Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562003
• Other study ID #: F061005016 (UAB 0643)
• Secondary ID: UAB 0643
• Status: Completed
• Phase: Phase 1
• First received: November 20, 2007
• Last updated: January 25, 2011
• Start date: June 2007
• Est. completion date: June 2010

Study information

• Verified date: January 2011
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Cancer

Intervention

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'.

Locations

Country	Name	City	State
United States	UAB Highlands, 1201 11th Ave S, 4th Floor, Gynecologic Oncology	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD		1 month	Yes
Secondary	To determine biologic, immunologic, and anti-tumor effects of Ad5-delta24RGD		1 month	Yes