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
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01989052 -
Ph 1/2 CTO With Lomustine for Bevacizumab-Naive Recurrent Glioma
|
Phase 1 |