Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients

Study Overview
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Brief Summary
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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

Official Title
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A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (Ad5-Delta 24 RGD)for Intraperitoneal Delivery in Ovarian and Extraovarian Cancer Patients (Infectivity Enhanced Virotherapy for Ovarian Cancer)

Conditions
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Ovarian Cancer, Primary Peritoneal Cancer

Intervention / Treatment
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* Procedure: Tenckhoff Catheter placement
* Drug: Ad5-delta24RGD


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Tenckhoff Catheter placement|'Tenckhoff catheter' will be placed into the abdominal cavity by a minor surgical procedure performed in the Radiology Department.|
|Drug: Ad5-delta24RGD|Within two weeks before the start of the study, a physical exam, blood tests, removal of fluid from abdominal cavity through the catheter and a CT scan of abdomen and pelvis will be performed. The procedure will involve receiving the Ad5-delta24RGD virus once a day for 3 days. The virus will be put into the abdominal cavity through a 'Tenckhoff catheter'.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine biologic, immunologic, and anti-tumor effects of Ad5-delta24RGD |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian cancer study