A Phase 1b Study of AdV-tk + Valacyclovir Gene Therapy in Combination With Standard Radiation Therapy for Malignant Gliomas
This study was designed to include patients with newly diagnosed unresectable (Arm A) and
resectable (Arm B) malignant glioma. Three dose levels of AdV-tk were evaluated with a fixed
dose level of valacyclovir prodrug. AdV-tk was delivered to tumor cells by stereotactic
injection into the tumor at the time of biopsy (Arm A) or injection into the tumor bed
following resection (Arm B). Oral valacyclovir began 1-3 days after the AdV-tk injection and
continued for 14 days. Standard radiation therapy began 3-7 days following the AdV-tk
injection to maximize synergy with radiation. Standard temozolomide could be administered
after completion of valacyclovir.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of the intervention will be evaluated based on laboratory and clinical parameters graded using CTCAEver3.
Through month 3 and long term follow up for late effects.
E. Antonio Chiocca, MD, PhD
Ohio State University
United States: Food and Drug Administration
|The Ohio State University Medical Center, Dept Neurosurgery||Columbus, Ohio 43210|
|The Methodist Hosptial||Houston, Texas 77030|