Valproic Acid in Childhood Progressive Brain Tumors

Phase 1WithdrawnNCT01861990

Medical University of South Carolina

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Pediatric Brain Tumor Glioma Anaplastic Astrocytoma Medulloblastoma Glioblastoma

Interventions

Valproic AcidDRUG

All participants enrolled on valproic acid arm.

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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)

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Completion of protocol

Number of participants completing the protocol will be measured.

Time frame: 2 months

Secondary Outcomes

Time to progression

Participants will be evaluated for progression every 2 months while on the study.

Time frame: 2 months

Data from ClinicalTrials.gov

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