drugset
drugset / Trial / NCT01891747

A Phase I Study of High-dose L-methylfolate in Combination With Temozolomide and Bevacizumab in Recurrent High Grade Glioma

NCT01891747 ↗

Phase 1 Completed 14 enrolled Vanderbilt-Ingram Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase I/II non-randomized prospective study of high-dose L-methylfolate in combination with bevacizumab and temozolomide in patients with recurrent high-grade glioma. The primary objective of this phase II trial is to determine whether the addition of high-dose L-methylfolate to bevacizumab and temozolomide therapy improves progression-free survival (PFS) compared to previously reported results.

Timeline

Start
2013-07
Primary completion
2015-06
Completion
2022-01-31

Drugs

EvaluationDrugModalityDoseRoute
Background Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Background Temozolomide Small molecule 150 mg/m2 —

Indications

malignant glioma