Valproic Acid, Radiation, and Bevacizumab in Children With High Grade Gliomas or Diffuse Intrinsic Pontine Glioma

Phase 2 Completed 38 enrolled Baylor College of Medicine Cook Children's Medical Center · collab M.D. Anderson Cancer Center · collab The University of Texas Health Science Center at San Antonio · collab University of Oklahoma · collab University of Texas, Southwestern Medical Center at Dallas · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2009-09-01
Primary completion: 2015-08-30
Completion: 2017-10-02

Outcome

Missed primary endpoint

paper CONCLUSION: Addition of VPA and bevacizumab to radiation was well tolerated but did not appear to improve EFS or OS in children with DIPG or HGG. PMID 32285998 ↗

Publications

Results Su JM, Murray JC, McNall-Knapp RY, Bowers DC, Shah S, Adesina AM, Paulino AC, Jo E, Mo Q, Baxter PA, Blaney SM. A phase 2 study of valproic acid and radiation, followed by maintenance valproic acid and bevacizumab in children with newly diagnosed diffuse intrinsic pontine glioma or high-grade glioma. Pediatr Blood Cancer. 2020 Jun;67(6):e28283. doi: 10.1002/pbc.28283. Epub 2020 Apr 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Valproic Acid	Small molecule	15 mg/kg	—