Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT00638612
Eligibility Criteria:
Inclusion Criteria:
* Must have presumed pancreatic adenocarcinoma based on clinical and radiologic evaluation with identifiable tumor accessible for injection (pathologic diagnosis of pancreatic adenocarcinoma must be made prior to AdV-tk injection
* For Arm A, resectable disease. Arm B for locally advanced disease has completed accrual.
* Performance status must be ECOG 0-2
* SGOT (AST)\<3x upper limit of normal
* Serum creatinine\<2mg/dl and calculated creatinine clearance \>10ml/min
* Platelets\>100,000/mm3 and WBC\>3000/mm3 and ANC\>1500/mm3
* Must give study specific informed consent prior to enrollment
Exclusion Criteria:
* Primary hepatic dysfunction including active hepatitis but not to exclude patients due to obstructive jaundice. If obstructive jaundice is clinically significant, bilirubin should be stable or decreasing prior to enrollment.
* Evidence of clinically significant pancreatitis as determined by the investigator.
* Patients on corticosteroids or other immunosuppressive drugs
* Known HIV+ patients
* Patients with acute infections (viral, bacterial or fungal infections requiring therapy)
* Pregnant or breast-feeding patients. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy
* Evidence of distant metastatic disease at the time of enrollment or other malignancy (except squamous or basal cell skin cancers) and no prior abdominal radiation therapy or prior treatment for pancreatic cancer
* Other serious co-morbid illness or compromised organ function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00638612
Study Brief:
Protocol Section:
NCT00638612