AdV-tk Therapy With Surgery and Chemoradiation for Pancreas Cancer (PaTK01)

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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 virus) engineered to express the Herpes thymidine kinase gene (AdV-tk), followed by an antiherpetic prodrug, valacyclovir.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Advantagene, Inc.; Candel Therapeutics, Inc.
• Treatments: Acyclovir; Pancrelipase; Valacyclovir

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