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valproic acid and radiation, followed by valproic acid and bevacizumab for Gliomas

Phase 2
Waitlist Available
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 11 to up to 24 months
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

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.

Eligible Conditions
  • Brain Cancer
  • Brain Tumor
  • Gliomas
  • Gliosarcoma
  • Glioblastoma
  • Anaplastic Astrocytoma
  • Malignant Glioma
  • Brain Stem Glioma
  • Diffuse Intrinsic Pontine Glioma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 11 to up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 11 to up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
1-year Event Free Survival (EFS)
Percentage Participants With Grade 2 Urinary Tract Infection, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab
Percentage of Grade 2 Hypertension, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab
+37 more
Secondary study objectives
Complete Response in High-grade Gliomas
Median Event Free Survival (EFS)
Median Overall Survival (OS)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: valproic acid and radiation, followed by valproic acid and bevacizumabExperimental Treatment3 Interventions
radiation phase (week 1-6): daily valproic acid and radiation, for approximately 6 weeks post-radiation phase (week 7-10): valproic acid daily maintenance phase (starting week 11): daily valproic acid, and bevacizumab once every 2 weeks; to continue for a maximum duration of 2 years
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valproic acid
FDA approved
Bevacizumab
FDA approved
Radiation therapy
2013
Completed Phase 3
~2850

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,022 Previous Clinical Trials
6,029,223 Total Patients Enrolled
Cook Children's Medical CenterOTHER
7 Previous Clinical Trials
1,868 Total Patients Enrolled
University of OklahomaOTHER
472 Previous Clinical Trials
93,605 Total Patients Enrolled
~2 spots leftby Nov 2025