Status:
COMPLETED
A Study of an Infectivity Enhanced Suicide Gene Expressing Adenovirus for Ovarian Cancer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
19+ years
Phase:
PHASE1
Brief Summary
In spite of surgical and chemotherapeutic advances, long term survival for advanced and recurrent gynecologic cancers remains dismal and no curative treatment for recurrent disease exists. Novel treat...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00964756
Start Date
August 1 2009
End Date
April 1 2012
Last Update
February 13 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294