Temozolomide, Bevacizumab, Lithium and Radiation Treatment for Newly Diagnosed High Grade Glioma: A Phase II Study
Cycle 1 (42-day cycle):
Temozolomide will be taken at a dose of 75 mg/m^2 orally, beginning the night prior to the
first radiation treatment. Duration of temozolomide treatment is 42 consecutive days.
Radiation therapy must begin within 3-5 weeks of surgery. Treatment of 1.8 Gy will be given
daily for 5 days per week, Monday through Friday. Treatment will continue for 33 fractions
for a total dose of 59.4 Gy over 6.5 weeks. All portals shall be treated during each
treatment session. Doses are specified as the target dose that shall be to the center of
the target volume.
Bevacizumab will be added to the temozolomide/radiation treatment plan 29(+3 if necessary)
days post surgery . This may be delayed to ensure that 28 days has elapsed between surgery
and the first dose of bevacizumab. No patient will be treated with bevacizumab before 28
days after a surgical procedure.
Bevacizumab treatment continues until the first post-treatment MRI is performed.
Radiological re-evaluation by MRI with gadolinium contrast with perfusion sequences will be
performed at 35 days (+ 2 days) after completion of radiation therapy. Assessment of
response will continue to be performed following every 2 cycles.
Treatment Cycle 2-7 (28 day cycles):
If the Cycle 1 post-treatment MRI is stable or without sign of recurrent tumor the
subsequent cycles (Cycles 2 - 7) will be administered as follows:
- Temozolomide at a dose of 150 mg/m^2 will be taken orally on Days 1-7
- Bevacizumab will be administered at a dose of 10 mg/kg per dosing administration on Day
8 and Day 22
- Magnetic Resonance Imaging is performed after every 2 cycles
Lithium Carbonate: Initiate treatment at 300 mg PO BID; increase dose every 7 days by 300 mg
to goal total dose of 1200 mg per day. Serum levels will than be assessed and dose adjusted
until therapeutic level of 0.8 to 1.2 mEq/L is reached. Adjust dose according to clinical
response and trough serum level (12 h) after steady state is reached (4-5 days).
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Tumor Progression
Deborah Gruber, MD
New York University Cancer Institute
United States: Institutional Review Board
|Overlook Hospital||Summit, New Jersey 07902-0220|
|New York University Clinical Cancer Center||New York, New York 10016|