NCT04105374View on ClinicalTrials.gov

Testing the Addition of an Anti-cancer Viral Gene Therapy, Toca 511/Toca FC, to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed Glioblastoma

PHASE2/PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 31, 2020

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2030

Conditions
Anaplastic AstrocytomaGlioblastomaOligodendrogliomaSupratentorial Glioblastoma
Interventions
DRUG

Extended Release Flucytosine

Given PO

DEVICE

NovoTTF-100A Device

Receive Optune device

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Radiation Therapy

Undergo radiation

DRUG

Temozolomide

Given PO

PROCEDURE

Therapeutic Conventional Surgery

Undergo standard of care surgery

BIOLOGICAL

Vocimagene Amiretrorepvec

Given via intracranial injection

Sponsors

Lead Sponsor

NRG Oncology
All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

NRG Oncology

OTHER