A Phase I Study of AD5.SSTR/TK.RGD; A Tropism Modified Adenovirus Vector for Intraperitoneal Delivery of Therapeutic Genes and Additional Capability of Noninvasive Imaging of Gene Transfer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers (Infectivity Enhanced Adenoviral Vectors for Ovarian CA)
- 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
- 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
- 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
- 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)