This study will evaluate the administration of AdV-tk followed by valacyclovir in children with malignant glioma, including glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), as well as recurrent ependymomas in combination with radiation therapy. The primary objective is to determine if this approach is safe and can be effectively delivered without disturbing standard therapy.
This is an Open label, Phase I, dose escalation study. Patients will receive an injection of AdV-tk into the tumor or tumor bed during the surgical procedure followed by 14 days of anti-herpetic prodrug, valacyclovir, starting 1-3 days after vector injection. Standard radiotherapy will begin 3-7 days after AdV-tK injection. Standard chemotherapy may begin after completion of valacyclovir at the discretion of the treating physician and family. Two dose levels of AdV-tk will be evaluated with a fixed dose of valacyclovir.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Ann & Robert H. Lurie Children's Hospital of Chicago (Formerly Children's Memorial Hospital)
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Incidence of treatment emergent adverse events
Time frame: 2 months
Overall survival
Time frame: 5 years
Progression-free survival
Time frame: 5 years
Objective tumor response
Time frame: 5 years
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