|
|
Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients
Basic Trial Information Trial Description Summary Eligibility Criteria Trial Contact Information
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
---|
Phase I | Treatment | Closed | 19 and over | F061005016 (UAB 0643) NCT00562003 |
Trial Description
Summary 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
Eligibility Criteria 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)
Trial Contact Information
Trial Lead Organizations/Sponsors Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham National Cancer Institute
Ronald D. Alvarez | | Principal Investigator |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00562003 Information obtained from ClinicalTrials.gov on April 16, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
|