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NCT01861990 Clinical Trial

Valproic Acid in Childhood Progressive Brain Tumors

Glioblastoma Clinical Trial

Official title:
Valproic Acid for Children With Recurrent and Progressive Brain Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01861990
Other study ID # VA2013
Secondary ID IRG-97-219-14
Status Withdrawn
Phase Phase 1
First received May 22, 2013
Last updated May 21, 2015
Start date May 2013
Est. completion date December 2013

Study information
Verified date May 2015
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority United States: Data and Safety Monitoring Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 1 Year and older
Eligibility 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)

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Valproic Acid
All participants enrolled on valproic acid arm.

Locations
Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (1)
Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (5)

Asklund T, Kvarnbrink S, Holmlund C, Wibom C, Bergenheim T, Henriksson R, Hedman H. Synergistic killing of glioblastoma stem-like cells by bortezomib and HDAC inhibitors. Anticancer Res. 2012 Jul;32(7):2407-13. — View Citation

Fu J, Shao CJ, Chen FR, Ng HK, Chen ZP. Autophagy induced by valproic acid is associated with oxidative stress in glioma cell lines. Neuro Oncol. 2010 Apr;12(4):328-40. doi: 10.1093/neuonc/nop005. Epub 2009 Oct 15. — View Citation

Masoudi A, Elopre M, Amini E, Nagel ME, Ater JL, Gopalakrishnan V, Wolff JE. Influence of valproic acid on outcome of high-grade gliomas in children. Anticancer Res. 2008 Jul-Aug;28(4C):2437-42. — View Citation

Van Nifterik KA, Van den Berg J, Slotman BJ, Lafleur MV, Sminia P, Stalpers LJ. Valproic acid sensitizes human glioma cells for temozolomide and ?-radiation. J Neurooncol. 2012 Mar;107(1):61-7. doi: 10.1007/s11060-011-0725-z. Epub 2011 Oct 26. — View Citation

Weller M, Gorlia T, Cairncross JG, van den Bent MJ, Mason W, Belanger K, Brandes AA, Bogdahn U, Macdonald DR, Forsyth P, Rossetti AO, Lacombe D, Mirimanoff RO, Vecht CJ, Stupp R. Prolonged survival with valproic acid use in the EORTC/NCIC temozolomide trial for glioblastoma. Neurology. 2011 Sep 20;77(12):1156-64. doi: 10.1212/WNL.0b013e31822f02e1. Epub 2011 Aug 31. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Completion of protocol Number of participants completing the protocol will be measured. 2 months Yes
Secondary Time to progression Participants will be evaluated for progression every 2 months while on the study. 2 months No
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