CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Valproic acid +2 moredrug
Likely dose
Valproic acid 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00879437
NCT00879437Phase 2Completed
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A Phase 2 Study of Valproic Acid and Radiation, Followed by Maintenance Valproic Acid and Bevacizumab in Children With Newly Diagnosed High-grade Gliomas or Brainstem Gliomas

Baylor College of Medicine·interventional·Posted Apr 10, 2009·Updated Jul 21, 2021

In Brief

A Phase 2 clinical trial evaluating Valproic acid, Bevacizumab, and 1 other intervention for Glial Cell Tumors and 7 related conditions. Completed, enrolled 38 participants across 6 sites.

Detailed Summary

Currently, there are few effective treatments for the following aggressive brain tumors: glioblastoma multiforme, anaplastic astrocytoma, gliomatosis cerebri, gliosarcoma, or brainstem glioma. Surgery and radiation can generally slow down these aggressive brain tumors, but in the majority of patients, these tumors will start growing again in 6-12 months. Adding chemotherapy drugs to surgery and radiation does not clearly improve the cure rate of children with malignant gliomas. The investigators are conducting this study to see if the combination of valproic acid and bevacizumab (also known as AvastinTM) with surgery and radiation will shrink these brain tumors more effectively and improve the chance of cure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlial Cell Tumors, Malignant Gliomas, Glioblastoma Multiforme, Anaplastic Astrocytoma, Gliomatosis Cerebri, Gliosarcoma, Brainstem Glioma, Diffuse Intrinsic Pontine Glioma
CountriesUnited States
CollaboratorsCook Children's Medical Center, University of Oklahoma, University of Texas, Southwestern Medical Center at Dallas, The University of Texas Health Science Center at San Antonio, M.D. Anderson Cancer Center

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 10, 2009
Enrollment StartSep 1, 2009
Primary CompletionAug 30, 2015
Study CompletionOct 2, 2017
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 17.2 years ago

Interventions

Valproic aciddrug

Daily (pre-XRT, During XRT, Post-XRT and Maintenance Therapy) Started at 15 mg/kg/day divided into three doses a day as soon as patients have recovered from surgery but no later than the first day of XRT. Dosage will be adjusted in increments of 5 mg/kg/day every 3-5 days to achieve and maintain trough concentrations between 85 and 115 mcg/ml

Bevacizumabdrug

All patients will receive bevacizumab (10 mg/kg iv) during the maintenance phase every two weeks for a maximum duration of therapy of 24 months.

Radiation therapyradiation

Radiation therapy will start within 30 days of the definitive surgical procedure. Primary brain malignant gliomas will receive a total dose of between 54.0 and 59.4 Gy in 30-33 fractions over 6-7 weeks. Total dose will be 54.0 Gy for completely resected tumors and brainstem gliomas. The total dose will be 59.4 if the tumor is located in the brain but not the brainstem, and the tumor was incompletely resected. Primary spinal cord malignant gliomas will receive a total dose of between 50.4-54 Gy in 28-30 fractions over 5-6 weeks.