Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Nicholas Butowski (ucsf)
Headshot of Nicholas Butowski
Nicholas Butowski

Description

Summary

This is a multicenter, open-label study of DB107-RRV (formerly Toca 511) and DB107-FC (formerly Toca FC) when administered following surgical resection in newly diagnosed High Grade Glioma (HGG) patients. The study is designed to evaluate whether treatment with DB107-RRV in combination with DB107-FC when added to standard of care provides clinical benefit to newly diagnosed HGG when compared to historical performance previously determined in well controlled clinical trials published in the peer reviewed literature. This study is going to be conducted in newly diagnosed HGG patients receiving with maximum surgical resection treatment followed by radiation and temozolomide treatment using the established Stupp Protocol for O6-methylguanine-DNA methyl-transferase (MGMT) methylated patients or radiation therapy for MGMT unmethylated patients.

Official Title

A Phase I/IIa Study to Evaluate the Efficacy of DB107-RRV (Formerly Toca511), Administered to Subjects At Time of Resection and Intravenously Thereafter, in Combination with DB107-FC (Formerly Toca FC) and Radiation Therapy or DB107-FC, Temozolomide (TMZ) and Radiation Therapy in Patients with Newly Diagnosed High Grade Glioma

Details

Keywords

High Grade Glioma, MGMT-Unmethylated Glioblastoma, MGMT-Methylated Glioblastoma, Gene therapy, Combination therapy, Glioblastoma, Glioma, Flucytosine, Temozolomide, DB107-RRV, Radiation Therapy (RT), Magnetic Resonance Imaging (MRI), Surgical resection, Low to High MGMT Methylation (DB107-RRV, DB107-FC, Temozolomide (TMZ), Radiation therapy)

Eligibility

Locations

  • University of California, San Diego accepting new patients
    San Diego California 92093 United States
  • University of California accepting new patients
    San Francisco California 94143 United States
  • University of Southern California accepting new patients
    Los Angeles California 90089 United States

Lead Scientist at University of California Health

  • Nicholas Butowski (ucsf)
    Dr. Nicholas Butowski is a neuro-oncologist who specializes in brain tumors, neuroimaging, cognitive and rehabilitative neurology, and complementary therapies for neurological disorders. He is director of clinical services in neuro-oncology and a researcher at the Brain Tumor Center.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06504381
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 70 study participants
Last Updated