Ph 1/2 CTO With Lomustine for Bevacizumab-Naive Recurrent Glioma
Status:
Terminated
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1/2 study of the combination of CTO with lomustine in patients with recurrent
malignant glioma to be treated at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at
Duke. The Primary Objectives are:
- Phase 1: To determine the maximum tolerated dose (MTD) of CTO when combined with
lomustine among patients with recurrent malignant glioma (World Health Organization
(WHO) grade III or IV) who have not been previously treated with bevacizumab.
- Phase 2: To assess the efficacy of CTO (either in monotherapy or in combination with
lomustine) compared to lomustine alone in patients with recurrent WHO grade IV malignant
gliomas that have not been previously treated with bevacizumab based upon 6-month
progression free survival (PFS6).
Note: This study was terminated early due to funding issues. At the time of termination, the
study was still in Phase 1 and no MTD for the combination of CTO and lomustine had been
determined for this population. Phase 2 will not proceed.