Canadian clinical trial registry

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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.

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Study Description

This study is to assess the effectiveness of molecular targeted therapy (four different possible medications) in addition to standard therapy for patients with a new diagnosis of high-risk neuroblastoma. The study also looks at the side effects associated with these medications.

The study also tests the effects of a drug called DFMO when added to the immunotherapy given as post-consolidation treatment.

Inclusion Criteria

• Age 1 to 22 years
• New diagnosis of high risk neuroblastoma
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This phase II trial studies how well the drug nirogacestat works in treating patients between the age of 1 to 18 years old with desmoid tumours that have grown after prior treatment and that cannot be removed by surgery. Nirogacestat works by blocking some of the chemicals that play a role in the growth of tumor cells. 

Inclusion Criteria

• Patient must have a desmoid tumor that is existing or that has come back (recurrent) and that cannot be removed by surgery
• Patients must be between 12 months to 18 years old 
• At minimum, patients must be up and about at least 50% of their waking hours 
• Blood work must come back within the acceptable ranges
• Patients must have adequate heart function 
• All patients and/or their parents or legal guardians must sign a written informed consent
• Your study doctor will discuss with you the medications you can and cannot take

Other inclusion and exclusion criteria may apply 

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Study Description

Venetoclax is a medication, taken by mouth, which selectively binds and blocks a molecule called BCL-2, restoring the ability for natural cell death in cancer cells that have the BCL-2 marker. It is expected to slow or stop the growth of cancer cells.

The aim of this study is to evaluate the dose, safety, tolerability, antitumor activity and other characteristics of venetoclax given with or without chemotherapy.

Inclusion Criteria

• Participants must have cancer that has come back or is not responding to current therapy
• Age up to 25 years
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

Some cancer, called hypermutant cancer, have been shown to have multiple genetic changes  or abnormalities that block DNA repair and favor tumour development. Nivolumab is a human monoclonal antibody that binds and blocks PD-1 on tumors cells.  The PD-1 pathway is an immune system checkpoint that may be used by cancer tumour cells to help them trick the immune system (escape surveillance) and avoid being destroyed. By blocking the PD-1 pathway, nivolumab reactivates cells from the patient immune system to help it identify and destroy the cancer cells. It is expected to slow or stop the growth of cancer cells.

In this phase I/II study, patients will not be randomized and all enrolled on the clinical trial will receive nivolumab.  The study will evaluate the dose, safety, tolerability, effect on the cancer and other important characteristics of nivolumab.  This study includes pediatric patients with recurrent or refractory hypermutant cancer aged 12 months to 18 years, including those with  bMMRD syndrome. for which no standard therapy is available or for which the subject is not eligible for the existing therapy.

Inclusion Criteria

•    Patients must be greater than 2 months and less than 25 years of age at time of enrollment. Please note, some hospitals may not be able to treat patients above certain ages (e.g., 18 years old).
•    Recurrent or relapse paediatric cancer suspected to be hypermutant, including those exhibiting evidence of genetic or molecular alterations such as: high microsatellite instability (MSI-H) in current or previous tumour, mutation causing loss of mismatch repair gene (MLH1, MSH2, MSH6, PMS2, EPCAM or MSH3) expression, hypermutation by local sequencing in current or previous tumour, a history of CMMRD, Lynch syndrome, xeroderma pigmentosum (XP), or other established disorder affiliated with an elevated hypermutation rate, a functional mutation of polymerase genes (POLE or POLD1) in current or previous tumour, a functionally impaired RRD pathway by other means; etc. 
•    Patients must have histologic or cytologic confirmation of malignancy at the time of initial diagnosis or relapse (as specified above). Patients with multiple concurrent and/or sequential neoplasms are eligible, including CNS and haematological malignancies.
•    Patients must be able to provide tumour sample (archival or a new biopsy). If a tumour sample (including archival) is not available, a new tumour sample may be needed. Any such biopsy will not be considered a trial-related procedure.

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This study is to evaluate the drug called BMS-986158 as a possible treatment for pediatric solid tumors, lymphoma, or brain tumors. BMS-986158 belongs to a group of drugs called "Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors". These drugs block proteins from the BET family that are important in reading part of the DNA involved in apoptosis and cell cycle progression. It is expected to slow or stop the growth of cancer cells.

The aim of this phase I study is to evaluate the dose, safety, tolerability, antitumor activity and other pharmacologic characteristics of BMS-986158 in children with refractory or relapsed pediatric solid tumors, lymphoma, or brain tumors for which no standard therapy is available or for which the subject is not eligible for the existing therapy.

Inclusion Criteria

• Age ≤ 21 years at time of enrollment.
• All patients must be able to swallow intact capsules.

• Participants must have evaluable or measurable disease and must have disease that is relapsed or refractory and for which standard curative measures do not exist or are no longer effective.

• Disease genetic alterations: MYCN amplification or high copy number gain, translocation involving MYC or MYCN, translocation involving BRD4 or BRD3

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This is a Phase 1 clinical trial designed to study a drug called 23ME-00610 in children and adults with advanced solid tumors that have not responded to or gotten worse after stardard therapy, or where no further standard therapy exists. In Part A of this study, researchers are looking to find the best possible dose of 23ME-00610 (called the recommended phase 2 dose). Part B of this study will evaluate how the patients body responds to the drug 23ME-00610 and continue monitoring safety. 

Inclusion Criteria

• To enroll in Part B of the study, the patient must be  ≥ 12 years of age
• Patient must weigh at least 40kg
• Patient must have a solid tumor:
  • that has progressed after all available standard therapy
  • or for which standard therapy has been ineffective
  • or for which no standard therapy exists
• Patient is up and about for at least half of their waking hours 
• Patient must have a solid tumor that has not previously been exposed to radiation

Additional inclusion or exclusion criteria may apply and will be discussed with you by the study team 

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Study Description

This study will assess the molecular subtype (abbreviated WNT, SHH, Non-WNT, Non-SHH) of patients with medulloblastoma. Based on the subtype And other factors, patients will be assigned to a "risk group", each risk group receiving specific treatment with chemotherapy and radiation therapy.

Patients with a specific molecular subtype called Sonic Hedgehog (SHH) will be treated with a medication taken by mouth, called vismodegib in addition to standard therapy, to directly target the molecular pathway. 

Inclusion Criteria

• Patients between 3 and 22 years of age with medulloblastoma.
• Patients between 22 and 40 years with medulloblastoma of the SHH subtype are eligible.
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.