Valproic Acid in Childhood Progressive Brain Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pediatric Brain Tumor Glioma Anaplastic Astrocytoma Medulloblastoma Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm

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.

Group Type EXPERIMENTAL

Valproic Acid

Intervention Type DRUG

All participants enrolled on valproic acid arm.

Interventions

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Valproic Acid

All participants enrolled on valproic acid arm.

Intervention Type DRUG

Other Intervention Names

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Valproate, VPA, Depakote, Depakote ER, Depakene

Eligibility Criteria

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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)

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No