Temodar (Temozolomide), Bevacizumab, Lithium and Radiation for High Grade Glioma
This is an open-label, Phase II study to estimate the effect on time to tumor progression and safety in patients with newly diagnosed high grade glioma.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Temozolomide, Bevacizumab, Lithium and Radiation Treatment for Newly Diagnosed High Grade Glioma: A Phase II Study|
- Time to Tumor Progression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Temozolomide, Bevacizumab, Lithium, Radiation
Cycle 1(One 42-day cycle)
Treatment Cycle 2-7 (28-day cycles)
Other Name: TemodarDrug: Bevacizumab
Other Name: AvastinDrug: Lithium
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).
|United States, New Jersey|
|Summit, New Jersey, United States, 07902|
|United States, New York|
|New York University Clinical Cancer Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Deborah Gruber, MD||New York University Cancer Institute|