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Valproic Acid in Childhood Progressive Brain Tumors

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 1 Year and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01861990
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Medical University of South Carolina
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Amy L Bredlau, MD
Principal Investigator Affiliation Medical University of South Carolina
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Withdrawn
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Pediatric Brain Tumor, Glioma, Anaplastic Astrocytoma, Medulloblastoma, Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Drug: - Valproic Acid

All participants enrolled on valproic acid arm.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Medical University of South Carolina, Charleston, South Carolina

Status

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

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