Valproic Acid in Childhood Progressive Brain Tumors

Phase 1

Withdrawn

• Conditions: Pediatric Brain Tumor; Glioma; Anaplastic Astrocytoma; Medulloblastoma; Glioblastoma
• Interventions: Drug: Valproic Acid

• Registration Number: NCT01861990
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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

Detailed Description

Patients with progressive or recurrent pediatric brain tumors are administered valproic acid, an HDAC inhibitor, along with standard of care therapy (radiation and temozolomide) for induction therapy. Thereafter, patients will be able to continue on valproic acid and temozolomide therapy as long as the combination is well tolerated and the tumor is not progressing.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-24
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Valproic Acid	All participants will be enrolled on to one, open-label arm. Participants will be treated with valproic acid in addition to standard of care therapy.

Primary Outcome Measures

Name	Time	Method
Completion of protocol	2 months	Number of participants completing the protocol will be measured.

Secondary Outcome Measures

Name	Time	Method
Time to progression	2 months	Participants will be evaluated for progression every 2 months while on the study.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States