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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

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Title
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ACNS1721 - A Phase 2 Study of Veliparib (ABT-888) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients With Newly Diagnosed High-Grade Glioma (HGG) Without H3 K27M or BRAFV600 Mutations

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ACNS1721 - A Phase 2 Study of Veliparib (ABT-888) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients With Newly Diagnosed High-Grade Glioma (HGG) Without H3 K27M or BRAFV600 Mutations

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DiagnosisAnaplastic Astrocytoma, Glioblastoma, Malignant GliomaStudy StatusClosed to enrollment
PhaseII
Age3 Years to 25 YearsRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationRadiation Therapy (Undergo radiation therapy) Drug: Temozolomide (Given by mouth) Drug: Veliparib (Given by mouth)
Last Posted Update2024-03-19
ClinicalTrials.gov #NCT03581292
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
Hamilton Health Sciences Centre, McMaster University - Dr. Uma H. Athale
Centres
Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 

 

 

Study Description

This study is aimed at improving the outcome for children with High Grade Glioma (HGG). Temozolomide, a medication taken by mouth, has been shown to improve survival in adults with glioblastoma, when taken during and after radiation. In this study, patients with a HGG that has specific molecular features (wild-type for H3-K27, IDH and BRAF) will receive experimental therapy of veliparib (given by mouth) during radiation therapy, followed by veliparib in combination with temozolomide.

This study will test whether this combination therapy may improve survival in children with newly diagnosed HGG that are wild-type for H3-K27, IDH and BRAF. Patients with IDH mutant glioma are also eligible. The outcomes of patients on this study will be compared to other patients with clinically and molecularly similar HGG treated with temozolomide alone.

(Retrieved from: https://www.childrensoncologygroup.org/acns1721)

Inclusion Criteria
  • Patients must be at least 3 years old and less than 22 years of age. Patients less than 25 years old may be eligible to enroll if they have a specific type of high grade glioma
  • Patients must have newly diagnosed High Grade Glioma, that does not include brainstem or spinal cord tumors, or disease that has spread to other parts of the body (metastatic disease)
  • Patients must agree to the study activities outlined in the consent forms; including MRI's, blood tests, biopsies etc - as they apply
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours
  • If the patient has a seizure disorder, they may be enrolled if the seizures are well-controlled
  • A written consent form must be signed by the patients and/or their parents/legal guardians

Other inclusion and exclusion criteria may apply and will be discussed with you by the study doctor.