Status:
WITHDRAWN
Valproic Acid in Childhood Progressive Brain Tumors
Lead Sponsor:
Medical University of South Carolina
Conditions:
Pediatric Brain Tumor
Glioma
Eligibility:
All Genders
1+ years
Phase:
PHASE1
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....
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01861990
Start Date
May 1 2013
End Date
December 1 2013
Last Update
May 22 2015
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425