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A Study of Bevacizumab Therapy in Patients With Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

A Study of Bevacizumab Therapy in Patients With Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas

A Pilot Study of Bevacizumab-Based Therapy in Patients With Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas

NCT00890786•Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

Summary

The outcome for children with high-grade gliomas and diffuse intrinsic brainstem gliomas remains poor despite the use of multi-modal therapy with surgery, radiation therapy and chemotherapy.

Detailed Description

Novel therapies are needed to improve the outcome of these children. Recent studies have demonstrated very promising results of treatment with bevacizumab/irinotecan in patients with recurrent high grade gliomas. Based on these promising results, and the tolerability of the irinotecan and bevacizumab in children with recurrent CNS malignancies both anecdotally and in a study conducted by the Pediatric Brain Tumor Consortium, we have designed a novel study incorporating concurrent radiation therapy with bevacizumab ± temozolomide followed by bevacizumab, irinotecan ±temozolomide in patients with newly diagnosed high-grade gliomas and diffuse intrinsic pontine gliomas.

Eligibility

Age

3 - 30 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must be ≥ 3 years of age and ≤ 30 years of age at the time of study entry.
•Diagnosis:
•* High-grade glioma;Patients must have had histologically verified anaplastic astrocytoma, glioblastoma multiforme or gliosarcoma.Patients with primary spinal cord tumors are eligible.
•* Diffuse intrinsic pontine glioma (DIPG) are eligible.
•Performance Level: Karnofsky ≥ 50% for patients \> 10 years of age and Lansky ≥ 50 for patients ≤ 10 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
•Prior Therapy: no prior anticancer therapy.
•Concomitant Medications: The use of steroids is permissible.
•Organ Function Requirements All patients must have adequate organ function as defined below.
•* Adequate Bone Marrow Function
•* Adequate Renal Function
+4 more criteria

Exclusion Criteria

•Patients with metastatic disease (i.e. M+ disease, or disease anywhere other than primary site).
•Patients with evidence of a new intracranial hemorrhage that is larger than a punctate size on baseline MRI scan.
•Allergies: Patients with a history of allergic reaction to Chinese hamster ovary cell products, or other recombinant human antibodies.
•Pregnant or breast feeding women will not be entered on this study.
•Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study.
•Infection: Patients who require IV antibiotics at time of enrollment, or who are currently receiving treatment for Clostridium difficile infection are excluded.
•Thrombosis: Patients must not have been previously diagnosed with a deep venous or arterial thrombosis (including pulmonary embolism), and must not have a known thrombophilic condition.
•Serious or Non-Healing Wounds
•Surgical Procedures: Patients who have had major surgery should not receive the first dose of bevacizumab until 28 days after major surgery.
•Patients with uncontrolled systemic hypertension.
+1 more criteria

Locations (2)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

May 1, 2009

Primary Completion Date

October 1, 2014

Completion Date

December 1, 2017

Last Updated

May 2, 2018

Enrollment

ACTUAL participants

Conditions

Newly Diagnosed High-Grade GliomasDiffuse Intrinsic Pontine Glioma

Interventions

Temozolomide

DRUG

Bevacizumab

DRUG

Irinotecan

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: May 2, 2018Data 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.

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A Study of Bevacizumab Therapy in Patients With Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

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

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