Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM

PHASE3RecruitingINTERVENTIONAL
Enrollment

432

Participants

Timeline

Start Date

April 27, 2022

Primary Completion Date

April 1, 2027

Study Completion Date

April 1, 2028

Conditions
GlioblastomaGlioblastoma MultiformeGlioma, MalignantGBMBrain CancerGlioblastoma, IDH-wildtypeGlioblastoma Multiforme, Adult
Interventions
DRUG

Repeated Superselective Intraarterial Cerebral infusion (SIACI) of Bevacizumab (Avastin) with Temozolomide and Radiation

Subjects who are assigned to the IA BV+TMZ/RT group (Treatment Group), in addition to your standard of care cancer treatment, you will have a dose of bevacizumab delivered directly to your brain through superselective intra-cranial intra-arterial catheterization of the arteries that supply blood to your brain tumor along with the start of the initial 42 day oral temozolomide treatment. IA BV will be repeated every three months for a total of 3 infusions.

DRUG

Temozolomide and Radiation Alone

Subjects who are assigned to the TMZ/RT alone group (Control Group) you will receive standard of care cancer treatment that involves a daily oral dose of temozolomide for 42 days with radiation to the tumor followed by 28 days of rest and then repeated maintenance treatment cycles of daily oral temozolomide 5 days on and 23 days off.

Trial Locations (1)

10075

RECRUITING

Lenox Hill Brain Tumor Center, New York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Northwell Health

OTHER