A Study of an Infectivity Enhanced Suicide Gene Expressing Adenovirus for Ovarian Cancer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers

Inclusion criteria

• Patients must have histologically documented invasive epithelial ovarian, extraovarian, fallopian tube or endometrial carcinoma.
• Patients must have persistent or recurrent disease after standard debulking/staging surgery and conventional therapy.
• 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, and hepatic function defined as:

• WBC > 3,000 ul
• Granulocytes > 1,500 ul
• Platelets > 100,000
• Creatinine clearance > 80 mg/dl or serum creatinine > 2.0
• Serum transaminases < 2.5 x upper limits of normal
• Normal serum bilirubin
• PT/PTT/INR < 1.5 x institutional ULN
• O2 saturation > or = 92 %
• Patients must be 19 years or older and must have signed informed consent

Exclusion criteria

• Patients with epithelial tumors of low malignant potential, stromal tumors and 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 hyper- tension, active or chronic debilitating pulmonary disease(i.e., active pneumonia, severe COPD, pulmonary edema, O2 saturation < 92%), or coagulation disorders (i.e. bleeding disorders, or on therapeutic anti- coagulants)