Phase 2a Study of AdV-tk With Standard Radiation Therapy for Malignant Glioma (BrTK02)
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
The purpose of this study was to evaluate the safety and potential efficacy of Gene Mediated
Cytotoxic Immunotherapy for malignant gliomas. The approach used an adenoviral vector
(disabled virus) engineered to express the Herpes thymidine kinase gene (aglatimagene
besadenovec, AdV-tk), followed by an antiherpetic prodrug, valacyclovir. The AdV-tk vector
was injected into the resection bed after standard tumor surgery and valacyclovir pills were
taken for 14 days. Standard radiation and chemotherapy were 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).