Newly Diagnosed High Grade Glioma (HGG) Clinical Trial
Official title:
The Toca 7 Study: A Phase 1b Study of the Safety of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Subjects With Newly Diagnosed High Grade Glioma Receiving Standard of Care
This is a multi-center, open label trial of combination therapy with Toca 511 and ascending doses of Toca FC added to the SOC for newly diagnosed HGG.
This is a multi-center, open label trial of combination therapy with Toca 511 and ascending
doses of Toca FC added to the SOC for newly diagnosed HGG.
Enrolled subjects with presumed newly diagnosed HGG will undergo planned resection of tumor.
Subjects with HGG will receive Toca 511, administered by intracranial parenchymal injection
into the walls of the resection cavity.
This study will establish the recommended Phase 2 dose of Toca FC to be used in combination
with standard of care chemoradiation and temozolomide in subjects with newly diagnosed HGG.
Subjects will begin chemoradiation treatment approximately 4 to 6 weeks after surgery. Oral
Toca FC (7-day courses) will be administered concurrent with the start of the second and
sixth weeks of chemoradiation during the concurrent treatment period, and concurrent with the
start of temozolomide during the maintenance treatment period.
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