A Phase 2a Study of AdV-tk + Valacyclovir Gene Therapy in Combination With Standard Radiation Therapy for Malignant Glioma
Up-front patients must have resectable or partially resectable malignant glioma and receive
injection of AdV-tk into remaining tumor or tumor bed after resection. Pathologic
confirmation of malignant glioma must be made prior to AdV-tk injection; if this is not
possible, the injection will not be performed and the subject will no longer be eligible for
the study.
Patients who have previously received AdV-tk + prodrug on this study may receive an
additional AdV-tk + prodrug course at recurrence if eligibility criteria are still met.
The dose level of AdV-tk is 3x10e11 vector particles. The oral prodrug, valacyclovir, is
started 1-3 days after AdV-tk injection and continue for 14 days. Standard radiotherapy will
begin 3-7 days after AdV-tk injection for the up-front course. For the recurrent course, if
radiation is indicated, it will also begin 3-7 days after AdV-tk injection.
Patients may receive temozolomide as per standard of care after completion of prodrug. For
recurrent administration, standard of care chemotherapy may be administered after completion
of prodrug.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Expand the safety evaluation at the maximum dose of AdV-tk evaluated in a completed phase Ib study
2 months
Yes
E. Antonio Chiocca, MD, PhD
Principal Investigator
Ohio State University
United States: Food and Drug Administration
BrTK02
NCT00589875
March 2007
December 2013
Name | Location |
---|---|
City of Hope Medical Center | Duarte, California 91010 |
The University of Chicago | Chicago, Illinois 60637 |
The Ohio State University Medical Center, Dept. Neurological Surgery | Columbus, Ohio 43210 |
The Methodist Hospital Neurological Institute | Houston, Texas 77030 |