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Valproic Acid in Childhood Progressive Brain Tumors

Primary Purpose

Pediatric Brain Tumor, Glioma, Anaplastic Astrocytoma

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Valproic Acid

About this trial

This is an interventional treatment trial for Pediatric Brain Tumor focused on measuring Glioma, Glioblastoma, Pediatric, Child, Brain tumor, Astrocytoma, Medulloblastoma, PNET

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Completion of protocol

Number of participants completing the protocol will be measured.

Secondary Outcome Measures

Time to progression

Participants will be evaluated for progression every 2 months while on the study.

Full Information

NCT ID

NCT01861990

First Posted

May 22, 2013

Last Updated

May 21, 2015

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT01861990

Brief Title

Valproic Acid in Childhood Progressive Brain Tumors

Official Title

Valproic Acid for Children With Recurrent and Progressive Brain Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Feasibility of the trial was proven to be absent.

Study Start Date

May 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Glioma, Glioblastoma, Pediatric, Child, Brain tumor, Astrocytoma, Medulloblastoma, PNET

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment arm

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Valproic Acid

Other Intervention Name(s)

Valproate, VPA, Depakote, Depakote ER, Depakene

Intervention Description

All participants enrolled on valproic acid arm.

Primary Outcome Measure Information:

Title

Completion of protocol

Description

Number of participants completing the protocol will be measured.

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Time to progression

Description

Participants will be evaluated for progression every 2 months while on the study.

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amy L Bredlau, MD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22037799

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 gamma-radiation. J Neurooncol. 2012 Mar;107(1):61-7. doi: 10.1007/s11060-011-0725-z. Epub 2011 Oct 26.

Results Reference

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PubMed Identifier

22753697

Citation

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.

Results Reference

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PubMed Identifier

20308311

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.

Results Reference

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PubMed Identifier

21880994

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.

Results Reference

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PubMed Identifier

18751431

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.

Results Reference

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Valproic Acid in Childhood Progressive Brain Tumors

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