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

The University of Alabama at Birmingham

Status and phase

Completed

Phase 1

Conditions

Primary Peritoneal Cancer

Ovarian Cancer

Treatments

Drug: Ad5-delta24RGD

Procedure: Tenckhoff Catheter placement

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00562003

UAB 0643

F061005016 (UAB 0643)

Details and patient eligibility

About

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

Enrollment

26 patients

Sex

Female

Ages

19+ years old

Volunteers

No 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)