Anaplastic Astrocytoma, Glioblastoma, Glioma, Medulloblastoma, Pediatric Brain Tumor
Conditions
Keywords
Glioma, Glioblastoma, Pediatric, Child, Brain tumor, Astrocytoma, Medulloblastoma, PNET
Brief summary
The study investigates valproic acid added to radiation and temozolomide therapy (standard of care) for progressive or recurrent pediatric brain tumors.
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.
Interventions
DRUGValproic Acid
All participants enrolled on valproic acid arm.
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of protocol | 2 months | Number of participants completing the protocol will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression | 2 months | Participants will be evaluated for progression every 2 months while on the study. |
Countries
United States
Outcome results
None listed