Valproic Acid in Childhood Progressive Brain Tumors

This study has been withdrawn prior to enrollment.
(Feasibility of the trial was proven to be absent.)
Sponsor:
Information provided by (Responsible Party):
Amy-Lee Bredlau, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01861990
First received: May 22, 2013
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Pediatric Brain Tumor
Glioma
Anaplastic Astrocytoma
Medulloblastoma
Glioblastoma
Drug: Valproic Acid
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Valproic Acid for Children With Recurrent and Progressive Brain Tumors

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Completion of protocol [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Number of participants completing the protocol will be measured.


Secondary Outcome Measures:
  • Time to progression [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Participants will be evaluated for progression every 2 months while on the study.


Enrollment: 0
Study Start Date: May 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Valproate, VPA, Depakote, Depakote ER, Depakene

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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01861990

Locations
United States, South Carolina
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 MUSC
  More Information

Publications:
Responsible Party: Amy-Lee Bredlau, Director, Pediatric Brain Tumor Program, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01861990     History of Changes
Other Study ID Numbers: VA2013, IRG-97-219-14
Study First Received: May 22, 2013
Last Updated: January 8, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Medical University of South Carolina:
Glioma
Glioblastoma
Pediatric
Child
Brain tumor
Astrocytoma
Medulloblastoma
PNET

Additional relevant MeSH terms:
Astrocytoma
Brain Neoplasms
Glioblastoma
Medulloblastoma
Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Glioma
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Valproic Acid
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014