Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients

Phase 1

Completed

• Conditions: Ovarian Cancer; Primary Peritoneal Cancer

• Registration Number: NCT00562003
• Lead Sponsor: University of Alabama at Birmingham

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-21
• Primary Completion: 2009-05
• Study Completion: 2010-06
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-25
• Last Update Posted: 2011-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD	1 month

Secondary Outcome Measures

Name	Time	Method
To determine biologic, immunologic, and anti-tumor effects of Ad5-delta24RGD	1 month

Trial Locations

Locations (1)

UAB Highlands, 1201 11th Ave S, 4th Floor, Gynecologic Oncology; 🇺🇸 Birmingham, Alabama, United States