Valproic Acid in Childhood Progressive Brain Tumors

• Status: Withdrawn
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study investigates valproic acid added to radiation and temozolomide therapy (standard of care) for progressive or recurrent pediatric brain tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• Subject, parent, or guardian willing and able to give informed consent

• Recurrent or progressive pediatric brain tumor, with MRI evidence of disease

• Age at first diagnosis of brain tumor 1-21 years old

• Lansky or Karnofsky performance score of at least 50 at diagnosis

Exclusion Criteria:

• Pregnancy

• Prior intolerance to valproic acid

• History of use of temozolomide

• Use of enzyme inducing anticonvulsant medications (see appendix B)

• Known urea cycle disorder (e.g. ornithine transcarbamylase deficiency)