Valproic Acid in Childhood Progressive Brain Tumors

May 21, 2015 updated by: Amy-Lee Bredlau, Medical University of South Carolina

Valproic Acid for Children With Recurrent and Progressive Brain Tumors

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Valproic Acid
All participants enrolled on valproic acid arm.
Other Names:
  • Valproate, VPA, Depakote, Depakote ER, Depakene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of protocol
Time Frame: 2 months
Number of participants completing the protocol will be measured.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression
Time Frame: 2 months
Participants will be evaluated for progression every 2 months while on the study.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Amy L Bredlau, MD, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (ESTIMATE)

May 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VA2013
  • IRG-97-219-14 (OTHER_GRANT: American Cancer Society Institutional Research Grant)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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