Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients

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:

• WBC> 3,000 ul
• Granulocytes> 1,500 ul
• Platelets> 100,000
• Creatinine clearance (actual or calculated) >80 mg/dl or serum creatinine <2.0
• Serum transaminases <2.5x upper limits of normal
• Normal serum bilirubin
• PT/PTT/INR < 1.5 x institutional ULN
• Ejection fraction on echocardiogram > 55%
• 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)