drugset

drugset / Trial / NCT01105702

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

NCT01105702 ↗

Phase 2 Terminated 28 enrolled NYU Langone Health Atlantic Health System · collab Genentech, Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2010-05
Primary completion: 2014-04
Completion: 2015-04

Publications

Background Wen PY, Macdonald DR, Reardon DA, Cloughesy TF, Sorensen AG, Galanis E, Degroot J, Wick W, Gilbert MR, Lassman AB, Tsien C, Mikkelsen T, Wong ET, Chamberlain MC, Stupp R, Lamborn KR, Vogelbaum MA, van den Bent MJ, Chang SM. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 2010 Apr 10;28(11):1963-72. doi: 10.1200/JCO.2009.26.3541. Epub 2010 Mar 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Lithium Carbonate	Unknown	600 mg	Oral
Subject	Temozolomide	Small molecule	150 mg/m2	Oral

Indications