NCT01861990

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

May 22, 2013

Last Update Submit

May 21, 2015

Conditions

Pediatric Brain TumorGliomaAnaplastic AstrocytomaMedulloblastomaGlioblastoma

Keywords

GliomaGlioblastomaPediatricChildBrain tumorAstrocytomaMedulloblastomaPNET

Outcome Measures

Primary Outcomes (1)

  • Completion of protocol

    Number of participants completing the protocol will be measured.

    2 months

Secondary Outcomes (1)

  • Time to progression

    2 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

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

Interventions

Valproic AcidDRUG

All participants enrolled on valproic acid arm.

Also known as: Valproate, VPA, Depakote, Depakote ER, Depakene
Treatment arm

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (5)

  • Van Nifterik KA, Van den Berg J, Slotman BJ, Lafleur MV, Sminia P, Stalpers LJ. Valproic acid sensitizes human glioma cells for temozolomide and gamma-radiation. J Neurooncol. 2012 Mar;107(1):61-7. doi: 10.1007/s11060-011-0725-z. Epub 2011 Oct 26.

    PMID: 22037799BACKGROUND

  • Asklund T, Kvarnbrink S, Holmlund C, Wibom C, Bergenheim T, Henriksson R, Hedman H. Synergistic killing of glioblastoma stem-like cells by bortezomib and HDAC inhibitors. Anticancer Res. 2012 Jul;32(7):2407-13.

    PMID: 22753697BACKGROUND

  • Fu J, Shao CJ, Chen FR, Ng HK, Chen ZP. Autophagy induced by valproic acid is associated with oxidative stress in glioma cell lines. Neuro Oncol. 2010 Apr;12(4):328-40. doi: 10.1093/neuonc/nop005. Epub 2009 Oct 15.

    PMID: 20308311BACKGROUND

  • Weller M, Gorlia T, Cairncross JG, van den Bent MJ, Mason W, Belanger K, Brandes AA, Bogdahn U, Macdonald DR, Forsyth P, Rossetti AO, Lacombe D, Mirimanoff RO, Vecht CJ, Stupp R. Prolonged survival with valproic acid use in the EORTC/NCIC temozolomide trial for glioblastoma. Neurology. 2011 Sep 20;77(12):1156-64. doi: 10.1212/WNL.0b013e31822f02e1. Epub 2011 Aug 31.

    PMID: 21880994BACKGROUND

  • Masoudi A, Elopre M, Amini E, Nagel ME, Ater JL, Gopalakrishnan V, Wolff JE. Influence of valproic acid on outcome of high-grade gliomas in children. Anticancer Res. 2008 Jul-Aug;28(4C):2437-42.

    PMID: 18751431BACKGROUND

MeSH Terms

Conditions

GliomaAstrocytomaMedulloblastomaGlioblastomaBrain NeoplasmsNeuroectodermal Tumors, Primitive

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Amy L Bredlau, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Pediatric Brain Tumor Program

Study Record Dates

First Submitted

May 22, 2013

First Posted

May 24, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

US(1)