Phase 1/2 CTO + Bevacizumab for Recurrent Glioma Post-Bevacizumab Failure

Malignant Glioma (WHO Grade III or IV) Clinical Trial

Official title: A Phase 1/2 Trial of Carboxyamidotriazole Orotate (CTO) Alone or in Combination With Bevacizumab for Adult Patients With Recurrent Malignant Glioma Post-Bevacizumab Failure

Status Terminated

Clinical Trial Summary

The primary objectives of the study are to determine the maximum tolerated dose (MTD) of Carboxyamidotriazole Orotate (CTO) when combined with standard dosing of bevacizumab among patients with recurrent malignant glioma (WHO grade III or IV) that have previously failed bevacizumab (Phase 1); to determine the activity of CTO alone in bevacizumab-failure WHO grade IV malignant glioma patients (Phase 2, Arm 1); to determine the activity of CTO plus bevacizumab in bevacizumab-failure WHO grade IV malignant glioma patients (Phase 2, Arm 2).

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 bevacizumab had been determined for this population. Phase 2 will not proceed.

Clinical Trial Description

In Phase 1 of the study, we will conduct a dose-escalation study of the combination of CTO with the standard dosing of bevacizumab among patients with recurrent malignant glioma (WHO Grade III or IV) that have previously failed bevacizumab. All patients will have also received standard treatment with radiation therapy and temozolomide prior to enrollment on study.

The Phase 2 portion of this study will investigate two novel treatment regimens sequentially. Each regimen will include 25 patients with recurrent WHO grade IV malignant glioma who have been treated in the past with standard radiation therapy, temozolomide, and bevacizumab. All patients must have failed therapy while on bevacizumab. Subjects in the first treatment regimen will receive CTO alone and subjects in the second treatment regimen will receive the combination of CTO and bevacizumab together.

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 bevacizumab had been determined for this population. Phase 2 will not proceed. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma (WHO Grade III or IV)

• NCT number: NCT01954030
• Study type: Interventional
• Source: Duke University
• Status: Terminated
• Phase: Phase 1
• Start date: October 2013
• Completion date: July 2015