Status:
COMPLETED
AdV-tk Therapy With Surgery and Chemoradiation for Pancreas Cancer (PaTK01)
Lead Sponsor:
Candel Therapeutics, Inc.
Conditions:
Pancreatic Adenocarcinoma
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this Phase 1 study is to evaluate the safety and potential efficacy of Gene Mediated Cytotoxic Immunotherapy for pancreatic cancer. The approach uses an adenoviral vector (disabled viru...
Detailed Description
The AdV-tk vector is injected into the tumor or tumor bed at the time of biopsy or standard tumor surgery after which valacyclovir pills are taken for 14 days. Two courses of AdV-tk, each followed by ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00638612
Start Date
August 1 2008
End Date
June 1 2015
Last Update
August 25 2023
Active Locations (3)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
Scripps Green Hospital/Scripps Cancer Center
La Jolla, California, United States, 92037
3
The Ohio State University
Columbus, Ohio, United States, 43210