TerminatedInterventionalPhase 1Last updated Aug 4, 2016

Ph 1/2 CTO With Lomustine for Bevacizumab-Naive Recurrent Glioma

A Phase 1/2 Unblinded Trial of Carboxyamidotriazole Orotate (CTO) Alone or in Combination With Lomustine for Bevacizumab-Naïve Adult Patients With Recurrent Malignant Glioma

Overview

ClinicalTrials.gov ID: NCT01989052
Lead Sponsor: Annick DesjardinsOTHER
Brief 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.

Status

Overall Status: Terminated
Start Date: May 2014
Primary Completion Date: Mar 2015Actual
Completion Date: Feb 2016Actual

Study Record Dates

First Submitted: Oct 21, 2013
First Submitted that Met QC Criteria: Nov 14, 2013
First Posted: Nov 20, 2013Estimated
Last Update Submitted that Met QC Criteria: Aug 2, 2016
Last Update Posted: Aug 4, 2016Estimated
Last Verified: Aug 2016

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