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Valproic Acid for Children With Recurrent and Progressive Brain Tumors


Phase 1
1 Year
N/A
Open (Enrolling)
Both
Pediatric Brain Tumor, Glioma, Anaplastic Astrocytoma, Medulloblastoma, Glioblastoma

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Trial Information

Valproic Acid for Children With Recurrent and Progressive 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.


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Completion of protocol

Outcome Description:

Number of participants completing the protocol will be measured.

Outcome Time Frame:

2 months

Safety Issue:

Yes

Authority:

United States: Data and Safety Monitoring Board

Study ID:

VA2013

NCT ID:

NCT01861990

Start Date:

May 2013

Completion Date:

Related Keywords:

  • Pediatric Brain Tumor
  • Glioma
  • Anaplastic Astrocytoma
  • Medulloblastoma
  • Glioblastoma
  • Glioma
  • Glioblastoma
  • Pediatric
  • Child
  • Brain tumor
  • Astrocytoma
  • Medulloblastoma
  • PNET
  • Astrocytoma
  • Brain Neoplasms
  • Glioblastoma
  • Glioma
  • Medulloblastoma

Name

Location

Medical University of South CarolinaCharleston, South Carolina  29425-0721