Loading clinical trials...

Erivedge (Vismodegib) in the Treatment of Pediatric Patients With Refractory Pontine Glioma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Erivedge (Vismodegib) in the Treatment of Pediatric Patients With Refractory Pontine Glioma

A Phase II, Open-label, Multi-center Study of Erivedge (Vismodegib) in the Treatment of Pediatric Patients With Refractory Pontine Glioma.

NCT01774253•Giselle Sholler

View on ClinicalTrials.gov

Summary

The purpose of this research study is to evaluate an investigational drug (Vismodegib) for Pontine Glioma that is growing or has come back (reoccurred). This study will look at the tumors response to the study drug, Vismodegib, and will also look at the safety and tolerability of Vismodegib. Vismodegib has been tested in multiple adult clinical trials and one pediatric trial. Laboratory testing in pontine gliomas suggests that this drug may be effective in treating this disease.

Eligibility

Age

3 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must have radiographically proven diffuse intrinsic pontine glioma and confirmation of residual disease after initial therapy or at the time of recurrence/progression as confirmed by MRI of the brain
•Subjects must be age ≥3 years and ≤ 18 years
•Diffuse intrinsic pontine glioma with measurable disease after receiving radiotherapy either concurrent with or followed by ≤ 2 prior courses of chemotherapy
•Measurable disease as defined by:
•Measurable tumor \>10mm by MRI
•Karnofsky performance status (PS) 60-100% (for patients \> 16 years of age) OR Lansky PS 60-100% (for patients ≤ 16 years of age)
•Body surface area \> 0.67 m2 and ≤ 2.21 m2
•Life expectancy of at least 2 months
•A negative urine pregnancy test is required for female participants of child bearing potential (≥13 years of age or after onset of menses)
•Acceptable liver function as defined by:
+20 more criteria

Exclusion Criteria

•Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, biologic therapy) other than the ones specified in the protocol. Patients must have discontinued the above cancer therapies for generally about 3 weeks (8 weeks for radiotherapy) prior to the first dose of study medication, as well as recovered from toxicity (to ≤ than grade 2 except for alopecia) induced by previous treatments.
•Currently receiving another investigational medicinal product.
•Uncontrolled concurrent illness including, but not limited to:
•1. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
•2. Diarrhea of any cause ≥ CTCAE grade 2
•3. Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary
•4. Any kind of malabsorption syndrome significantly affecting gastrointestinal function
•Pregnant or nursing female patients. NOTE: If a female patient becomes pregnant or suspects that she is pregnant while participating in this study, she should stop taking study drug and immediately inform her treating physician immediately.
•Prior therapy with a Hedgehog inhibitor
•Unwillingness or inability to comply with procedures required in this protocol
+2 more criteria

Locations (2)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Key Dates

Start Date

May 1, 2013

Primary Completion Date

October 1, 2015

Completion Date

October 1, 2015

Last Updated

August 6, 2024

Enrollment

ACTUAL participants

Conditions

Pontine Glioma

Interventions

Vismodegib

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

View study

RECRUITINGPHASE1

rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG

NCT04943848

Diffuse Intrinsic Pontine GliomaDiffuse Midline Glioma, H3 K27M-Mutant

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Erivedge (Vismodegib) in the Treatment of Pediatric Patients With Refractory Pontine Glioma

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG

CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma

Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age

Safety and Efficacy of Loco-regional B7H3 IL-7Ra CAR T Cell in DIPG

A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma