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Valproic Acid in Childhood Progressive Brain Tumors

Sponsor
Medical University of South Carolina (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01861990
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
7
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Valproic Acid
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Valproic Acid for Children With Recurrent and Progressive Brain Tumors
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Completion of protocol [2 months]

      Number of participants completing the protocol will be measured.

    Secondary Outcome Measures

    1. Time to progression [2 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of South Carolina Charleston South Carolina United States 29425

    Sponsors and Collaborators

    • Medical University of South Carolina

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Amy-Lee Bredlau, Director, Pediatric Brain Tumor Program, Medical University of South Carolina
    ClinicalTrials.gov Identifier:
    NCT01861990
    Other Study ID Numbers:
    • VA2013
    • IRG-97-219-14
    First Posted:
    May 24, 2013
    Last Update Posted:
    May 22, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Amy-Lee Bredlau, Director, Pediatric Brain Tumor Program, Medical University of South Carolina
    Glioma
    Glioblastoma
    Pediatric
    Child
    Brain tumor
    Astrocytoma
    Medulloblastoma
    PNET
    Additional relevant MeSH terms:
    Glioblastoma
    Brain Neoplasms
    Astrocytoma
    Medulloblastoma
    Valproic Acid

    Study Results

    No Results Posted as of May 22, 2015