Clinical trial

AdV-tk + Valacyclovir Therapy in Combination With Surgery and Chemoradiation for Pancreas Cancer

Name

PaTK01

Description

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.

Trial arms

Trial start

2008-08-01

Estimated PCD

2013-05-01

Trial end

2015-06-01

Status

Completed

Phase

Early phase I

Treatment

AdV-tk

Four dose levels of AdV-tk with a fixed dose level of valacyclovir are evaluated independently in the two arms of the study due to differences in the concomitant standard of care treatments. The first AdV-tk course is given prior to surgery or radiation by CT or EUS guided injection into the tumor followed by 14 days of valacyclovir. The second AdV-tk injection is into the tumor bed at the time of surgery in Arm A or same as the first injection in Arm B again followed by 14 days of valacyclovir. The AdV-tk dose levels are: Level 1= 3x10e10 vector particles (vp), Level 2= 1x10e11 vp, Level 3= 3x10e11 vp, Level 4= 1x10e12 vp

Arms:

A resectable, B locally advanced

Valacyclovir

Valacyclovir caplets at a dose of 2 grams orally three times per day is administered for 14 days starting 1-3 days after each of the two AdV-tk injections in both arms.

Arms:

A resectable, B locally advanced

Other names:

Valtrex

Size

Primary endpoint

Incidence of treatment emergent adverse events

2 months

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 27, 'type': 'ACTUAL'}}

Updated at

2023-08-25

1 organization

2 products

2 indications

Product

AdV-tk

Indication

Pancreatic adenocarcinoma

Indication

Pancreatic Cancer

Product

Valacyclovir

Organization

Candel Therapeutics