Page last updated: 2024-10-26

valproic acid and Brain Stem Neoplasms

valproic acid has been researched along with Brain Stem Neoplasms in 3 studies

Valproic Acid: A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.
valproic acid : A branched-chain saturated fatty acid that comprises of a propyl substituent on a pentanoic acid stem.

Brain Stem Neoplasms: Benign and malignant intra-axial tumors of the MESENCEPHALON; PONS; or MEDULLA OBLONGATA of the BRAIN STEM. Primary and metastatic neoplasms may occur in this location. Clinical features include ATAXIA, cranial neuropathies (see CRANIAL NERVE DISEASES), NAUSEA, hemiparesis (see HEMIPLEGIA), and quadriparesis. Primary brain stem neoplasms are more frequent in children. Histologic subtypes include GLIOMA; HEMANGIOBLASTOMA; GANGLIOGLIOMA; and EPENDYMOMA.

Research Excerpts

ExcerptRelevanceReference
"To study the efficacy and tolerability of valproic acid (VPA) and radiation, followed by VPA and bevacizumab in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG)."9.34A phase 2 study of valproic acid and radiation, followed by maintenance valproic acid and bevacizumab in children with newly diagnosed diffuse intrinsic pontine glioma or high-grade glioma. ( Adesina, AM; Baxter, PA; Blaney, SM; Bowers, DC; Jo, E; McNall-Knapp, RY; Mo, Q; Murray, JC; Paulino, AC; Shah, S; Su, JM, 2020)
"To study the efficacy and tolerability of valproic acid (VPA) and radiation, followed by VPA and bevacizumab in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG)."5.34A phase 2 study of valproic acid and radiation, followed by maintenance valproic acid and bevacizumab in children with newly diagnosed diffuse intrinsic pontine glioma or high-grade glioma. ( Adesina, AM; Baxter, PA; Blaney, SM; Bowers, DC; Jo, E; McNall-Knapp, RY; Mo, Q; Murray, JC; Paulino, AC; Shah, S; Su, JM, 2020)

Research

Studies (3)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's2 (66.67)24.3611
2020's1 (33.33)2.80

Authors

AuthorsStudies
Su, JM1
Murray, JC1
McNall-Knapp, RY1
Bowers, DC1
Shah, S1
Adesina, AM1
Paulino, AC1
Jo, E1
Mo, Q1
Baxter, PA1
Blaney, SM1
Killick-Cole, CL1
Singleton, WGB1
Bienemann, AS1
Asby, DJ1
Wyatt, MJ1
Boulter, LJ1
Barua, NU1
Gill, SS1
Felix, FH1
de Araujo, OL1
da Trindade, KM1
Trompieri, NM1
Fontenele, JB1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 2 Study of Valproic Acid and Radiation, Followed by Maintenance Valproic Acid and Bevacizumab in Children With Newly Diagnosed High-grade Gliomas or Brainstem Gliomas[NCT00879437]Phase 238 participants (Actual)Interventional2009-09-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

1-year Event Free Survival (EFS)

To compare 1-year EFS for this trial versus historical series (ACNS0126 for high-grade gliomas; CCG-9941 for DIPG) (NCT00879437)
Timeframe: 12 months

Interventionpercentage of participants (Number)
Diffuse Intrinsic Pontine Glioma12
High-grade Gliomas24

Complete Response in High-grade Gliomas

complete response defined as complete disappearance of all measurable lesions,determined using WHO bi-dimensional criteria (product of the greatest tumor diameter and its perpendicular diameter) (NCT00879437)
Timeframe: up to 24 months

InterventionParticipants (Count of Participants)
High-grade Gliomas1

Median Event Free Survival (EFS)

estimate the median event free survival of patients receiving protocol therapy (NCT00879437)
Timeframe: 24 months

Interventionmonths (Median)
Diffuse Intrinsic Pontine Glioma7.8
High-grade Gliomas9.1

Median Overall Survival (OS)

median OS of patients receiving protocol therapy (NCT00879437)
Timeframe: 24 months

Interventionmonths (Median)
Diffuse Intrinsic Pontine Glioma10.3
High-grade Gliomas12.1

Partial Response in Diffuse Intrinsic Pontine Glioma

partial response defined as 51% to 99% reduction in tumor size,determined using WHO bi-dimensional criteria (product of the greatest tumor diameter and its perpendicular diameter) (NCT00879437)
Timeframe: up to 24 months

InterventionParticipants (Count of Participants)
Diffuse Intrinsic Pontine Glioma8

Partial Response in High-grade Gliomas

partial response defined as 51% to 99% reduction in tumor size,determined using WHO bi-dimensional criteria (product of the greatest tumor diameter and its perpendicular diameter) (NCT00879437)
Timeframe: up to 24 months

InterventionParticipants (Count of Participants)
High-grade Gliomas5

Percentage of Grade 2 Hypertension, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

Document frequency of grade 2 hypertension, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients8

Percentage of Participants With Grade 1 Cystitis, Assessed by CTCAE v3.0, During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 2 cystitis, assessed by CTCAE v3.0, during concurrent valproic acid and radiation treatment from week 1-10 (NCT00879437)
Timeframe: first 10 weeks of therapy

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 2 Abdominal Pain, Assessed by CTCAE v3.0, During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 2 abdominal pain, assessed by CTCAE v3.0, during concurrent valproic acid and radiation treatment, week 1-10 (NCT00879437)
Timeframe: first 10 weeks of therapy

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 2 Abdominal Pain, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 2 abdominal pain, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 2 Anorexia, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 2 anorexia, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients3

Percentage of Participants With Grade 2 AST Elevation, Assessed by CTCAE v3.0, During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 2 AST elevation, assessed by CTCAE v3.0, during concurrent valproic acid and radiation treatment from week 1-10 (NCT00879437)
Timeframe: first 10 weeks of therapy

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 2 Cough, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 2 cough, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 2 Fatigue, Assessed by CTCAE v3.0, During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 2 fatigue, assessed by CTCAE v3.0, during concurrent valproic acid and radiation treatment from week 1-10 (NCT00879437)
Timeframe: first 10 weeks of study

InterventionParticipants (Count of Participants)
38 Eligible Patients3

Percentage of Participants With Grade 2 Fatigue, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 2 or higher fatigue, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients7

Percentage of Participants With Grade 2 Hypoalbuminemia, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 2 hypoalbuminemia, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients3

Percentage of Participants With Grade 2 Hypoglycemia, Assessed by CTCAE v3.0, During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 2 hypoglycemia, assessed by CTCAE v3.0, during concurrent valproic acid and radiation treatment from week 1-10 (NCT00879437)
Timeframe: first 10 weeks of study

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 2 Hypoglycemia, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 2 hypoglycemia, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 2 Intratumoral/Intracranial Hemorrhage, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 2 intratumoral/intracranial hemorrhage, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 2 Ocular Keratitis, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 2 ocular keratitis, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 2 Pancreatitis, Assessed by CTCAE v3.0, During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 2 pancreatitis, assessed by CTCAE v3.0, during concurrent valproic acid and radiation treatment from week 1-10 (NCT00879437)
Timeframe: first 10 weeks of study

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 2 Proteinuria, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 2 proteinuria, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients2

Percentage of Participants With Grade 2 Somnolence, Assessed by CTCAE v3.0, During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 2 somnolence, assessed by CTCAE v3.0, during concurrent valproic acid and radiation treatment from week 1-10 (NCT00879437)
Timeframe: first 10 weeks of study

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 2 Somonolence, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 2 somnolence, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients2

Percentage of Participants With Grade 2 Weight Gain, Assessed by CTCAE v3.0, During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 2 weight gain, assessed by CTCAE v3.0, during concurrent valproic acid and radiation treatment from week 1-10 (NCT00879437)
Timeframe: first 10 weeks of study

InterventionParticipants (Count of Participants)
38 Eligible Patients4

Percentage of Participants With Grade 2 Weight Gain, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of 2 weight gain, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 3 Cellulitis, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 3 cellulitis, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 3 Dehydration, Assessed by CTCAE v3.0, During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 3 dehydration, assessed by CTCAE v3.0, during concurrent valproic acid and radiation treatment from week 1-10 (NCT00879437)
Timeframe: first 10 weeks of therapy

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 3 Fatigue, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

Document frequency of grade 3 fatigue, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients3

Percentage of Participants With Grade 3 Hypertension, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 3 hypertension, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients4

Percentage of Participants With Grade 3 Leukopenia, Assessed by CTCAE v3.0, During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 3 leukopenia, assessed by CTCAE v3.0, during concurrent valproic acid and radiation treatment from week 1-10 (NCT00879437)
Timeframe: first 10 weeks of study

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 3 Lipase and Amylase Elevation, Assessed by CTCAE v3.0, During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 3 lipase and amylase elevation, assessed by CTCAE v3.0, during concurrent valproic acid and radiation treatment from week 1-10 (NCT00879437)
Timeframe: first 10 weeks of therapy

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 3 Lymphopenia Assessed by CTCAE v3.0 During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 3 lymphopenia, assessed by CTCAE v3.0, during concurrent valproic acid and radiation treatment from week 1-10 (NCT00879437)
Timeframe: first 10 weeks of study

InterventionParticipants (Count of Participants)
38 Eligible Patients5

Percentage of Participants With Grade 3 Lymphopenia, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 3 lymphopenia, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients3

Percentage of Participants With Grade 3 Neutropenia Assessed by CTCAE v3.0 During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 3 neutropenia, graded by CTCAE v3.0, during concurrent valproic acid and radiation treatment for the first 10 weeks (NCT00879437)
Timeframe: first 10 weeks of study

InterventionParticipants (Count of Participants)
38 Eligible Patients3

Percentage of Participants With Grade 3 Neutropenia, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 3 neutropenia, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients3

Percentage of Participants With Grade 3 Somonolence, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

Document frequency of grade 3 somonolence, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 3 Subacute Bone Infarction, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 3 subacute bone infarction, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 3 Thrombocytopenia Assessed by CTCAE v3.0 During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 3 thrombocytopenia, graded according to CTCAE v3.0, during concurrent valproic acid and radiation treatment for week 1-10 (NCT00879437)
Timeframe: first 10 weeks of study

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 3 Thrombocytopenia, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 3 thrombocytopenia, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients3

Percentage of Participants With Grade 3 Weight Gain, Assessed by CTCAE v3.0, During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 3 weight gain, assessed by CTCAE v3.0, during concurrent valproic acid and radiation treatment during week 1-10 (NCT00879437)
Timeframe: first 10 weeks of study

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 3 Weight Gain, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

Document frequency of grade 3 weight gain, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients2

Percentage of Participants With Grade 4 Deep Vein Thrombosis, Pulmonary Embolism, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 4 deep vein thrombosis, pulmonary embolism, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage of Participants With Grade 4 Radiation Necrosis, Assessed by CTCAE v3.0, During Concurrent Valproic Acid and Radiation Treatment

document frequency of grade 4 radiation necrosis, assessed by CTCAE v3.0, during concurrent valproic acid and radiation treatment from week 1-10 (NCT00879437)
Timeframe: first 10 weeks of therapy

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Percentage Participants With Grade 2 Urinary Tract Infection, Assessed by CTCAE v3.0, During Maintenance Therapy of Valproic Acid and Bevacizumab

document frequency of grade 2 urinary tract infection, assessed by CTCAE v3.0, during maintenance therapy of valproic acid and bevacizumab, from week 11 to up to 24 months (NCT00879437)
Timeframe: from week 11 to up to 24 months

InterventionParticipants (Count of Participants)
38 Eligible Patients1

Trials

1 trial available for valproic acid and Brain Stem Neoplasms

ArticleYear
A phase 2 study of valproic acid and radiation, followed by maintenance valproic acid and bevacizumab in children with newly diagnosed diffuse intrinsic pontine glioma or high-grade glioma.
    Pediatric blood & cancer, 2020, Volume: 67, Issue:6

    Topics: Adolescent; Adult; Antineoplastic Combined Chemotherapy Protocols; Bevacizumab; Brain Stem Neoplasms

2020

Other Studies

2 other studies available for valproic acid and Brain Stem Neoplasms

ArticleYear
Repurposing the anti-epileptic drug sodium valproate as an adjuvant treatment for diffuse intrinsic pontine glioma.
    PloS one, 2017, Volume: 12, Issue:5

    Topics: Acetylation; Adjuvants, Pharmaceutic; Animals; Anticonvulsants; Apoptosis; Brain Stem Neoplasms; Cel

2017
Retrospective evaluation of the outcomes of children with diffuse intrinsic pontine glioma treated with radiochemotherapy and valproic acid in a single center.
    Journal of neuro-oncology, 2014, Volume: 116, Issue:2

    Topics: Adolescent; Antineoplastic Agents; Brain Stem Neoplasms; Carboplatin; Child; Child, Preschool; Femal

2014