Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Pharmaceutical / Industry	BrTK02 5R44CA107745, NCT00589875

Trial Description

Summary

The purpose of this study is to evaluate the safety and potential efficacy of Gene Mediated Cytotoxic Immunotherapy for malignant gliomas. 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 bed after standard tumor surgery and valacyclovir pills are taken for 14 days. Standard radiation and chemotherapy are administered which have been shown to work cooperatively with AdV-tk + prodrug to kill tumor cells. The hypothesis is that this combination therapy can be safely delivered and will lead to improvement in the clinical outcome for patients with newly diagnosed malignant gliomas, including glioblastoma multiforme (WHO grade IV) and anaplastic astrocytomas (WHO grade III).

Eligibility Criteria

Inclusion Criteria:

• Must have presumed malignant glioma based on clinical and radiologic evaluation and pathologic confirmation of malignant glioma must be made at the time of surgery if not previously determined

• Tumor must be accessible for injection and must not be located in the brainstem, midbrain, contained within the ventricular system, or located in an infratentorial location.

• Must be planning to undergo standard radiation therapy.

• Performance status KPS 70 or more.

• 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.

• Patients of reproductive age must agree to use a medically accepted form of birth control while on the study.

• Must give study specific informed consent prior to enrollment.

• Must be able to tolerate MRI scan procedure

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.

• Patients on immunosuppressive drugs (with exception of corticosteroid)

• Known HIV+ patients.

• 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 metastatic disease or other malignancy (except squamous or basal cell skin cancers).

• Prior radiation therapy to the brain or prior treatment for brain tumor (except prior biopsy or subtotal resection).

• Other serious co-morbid illness or compromised organ function.

• May not receive temozolomide until valacyclovir completed

• May not receive other investigational anti-tumor agents within 30 days prior to study entry or during active participation in the study (defined as from study entry until tumor progression).

Trial Contact Information

Trial Lead Organizations/Sponsors

Advantagene, Incorporated

E. Antonio Chiocca

Principal Investigator

U.S.A.
California
	Duarte
	City of Hope Comprehensive Cancer Center
		Greta Manila, NP	Ph: 626-471-9393
		Roger Harthrong, NP	Ph: 626-471-9393
		Jana Portnow	Principal Investigator
Ohio
	Columbus
	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
		Susan D Bell, RN,MS	Ph: 614-293-3143
			Email: Susan.Bell@osumc.edu
		E. Antonio Chiocca, MD, PhD	Ph: 614-293-9312
		E. Antonio Chiocca	Principal Investigator
Texas
	Houston
	Methodist Hospital
		Pamela Z. New, MD	Ph: 713-441-3800
			Email: pnew@tmhs.org
		Pamela Z. New	Principal Investigator
		David Baskin, MD	Sub-Investigator
		Todd Trask, MD	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00589875
Information obtained from ClinicalTrials.gov on March 18, 2009