Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	18 and over	Pharmaceutical / Industry	PaTK01 1R43CA119847, NCT00638612

Trial Description

Summary

The purpose of this 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. 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.

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

• No evidence of metastases

• For Arm A, resectable disease. For Arm B, locally advanced disease.

• 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:

• Prior or ongoing liver disease including known cirrhosis, hepatitis B or C infection but not to exclude patients with a distant history of resolved hepatitis A infection

• Clinical pancreatitis in past 3 months

• 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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Advantagene, Incorporated

Mark Bloomston, MD

Principal Investigator

U.S.A.
California
	Duarte
	City of Hope Comprehensive Cancer Center
		Vincent Chung, MD	Ph: 626-471-9200
		Carol Rose	Ph: 626-359-8111 Ext.62845
			Email: crose@coh.org
		Vincent Chung	Principal Investigator
	La Jolla
	Scripps Green Hospital/Scripps Cancer Center
		Deandra Holland, RN, BSN	Ph: 858-652-5445
			Email: holland.deandra@scrippshealth.org
		Christopher Marsh, MD	Principal Investigator
Ohio
	Columbus
	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
		Mark Bloomston, MD	Ph: 866-627-7616
			Email: osu@emergingmed.com
		Mark Bloomston, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00638612
Information obtained from ClinicalTrials.gov on March 18, 2009