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

Pancreatic Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 valacyclovir, are given as adjuvant to standard of care therapies (surgery and/or chemoradiation) which have been shown to work cooperatively with AdV-tk to kill tumor cells. Arm A is for resectable tumors in which the first course is given prior to surgery and the second is at the time of surgery. Arm B is for locally advanced disease in which both AdV-tk injections are administered by needle injection into the tumor before and during chemoradiation. The hypothesis is that this combination therapy can be safely delivered and will lead to improvement in the clinical outcome for patients with pancreatic cancer. ;

Related Conditions & MeSH terms

• Pancreatic Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT00638612
• Study type: Interventional
• Source: Candel Therapeutics, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: August 2008
• Completion date: June 2015