Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Brain Neoplasms

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Central Nervous System Depressants

Psychotropic Drugs

Bevacizumab

Temozolomide

Lithium Carbonate

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antidepressive Agents

Enzyme Inhibitors

Cycle 1(One 42-day cycle)

* Temozolomide 75 mg/m\^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment
* Radiation within 3-5 weeks of surgery
* Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks

Treatment Cycles 2-7 (28 days per cycle)

* Temozolomide at a dose of 150 mg/m\^2 on Days 1-7
* Bevacizumab 10 mg/kg on Day 8 and Day 22
* Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L.

Radiation

Deborah Gruber, MD

This pilot phase II trial studies how well giving temozolomide, bevacizumab, lithium carbonate, and radiation therapy works in treating patients with newly diagnosed high grade glioma.

Treatment of high grade glioma (HGG) with anti-angiogenic therapy results in clinical improvement and prolonged progression-free survival (PFS). However, mant patients experience diffuse recurrence and treatment failure. This is a phase II trial testing the feasibility of adding lithium carbonate, previously shown to have anti-invasive properties in HGG, to bevacizumab and chemoradiation following surgical resection of HGG.

Temodar (Temozolomide), Bevacizumab, Lithium and Radiation for High Grade Glioma

Temozolomide, Bevacizumab, Lithium and Radiation Treatment for Newly Diagnosed High Grade Glioma: A Phase II Study

PFS defined as time from date of diagnosis to most recent follow up, disease progression, or death. Disease progress defined as either clinical deterioration or radiographic progressive disease on magnetic resonance imaging (MRI) per updated response assessment in neuro-oncology criteria (Wen, et al).

OS defined as time from diagnosis to most recent follow up or death.

Genentech, Inc.

Atlantic Health System

NYU Langone Health

TBL/RT

Age, Continuous

Sex: Female, Male

Caucasian

Asian

Hispanic

Race/Ethnicity, Customized

United States

Region of Enrollment

Grade III

Grade IV

Grade III: Malignant although there is not always a big difference between grade II and grade III tumors. The cells of a grade III tumor are actively reproducing abnormal cells, which grow into nearby normal brain tissue. These tumors tend to recur, often as a grade IV.

Grade IV: These are the most malignant tumors. They reproduce rapidly, can have a bizarre appearance when viewed under the microscope, and easily grow into nearby normal brain tissue. These tumors form new blood vessels so they can maintain their rapid growth.

Spots Global Cancer Trial Database for Temodar (Temozolomide), Bevacizumab, Lithium and Radiation for High Grade Glioma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial