Valproic Acid for Children With Recurrent and Progressive Brain Tumors
1 Year
N/A
Both
Pediatric Brain Tumor, Glioma, Anaplastic Astrocytoma, Medulloblastoma, Glioblastoma
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 Carolina | Charleston, South Carolina 29425-0721 |
