Canadian clinical trial registry

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Study Description

This is a Phase 2 trial for newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of combining the drug naxitamab with standard induction therapy. Initially, there will be 5 cycles of standard chemotherapy with Naxitamab on days 1, 3 and 5 of each cycle. Patients with an ALK mutation or amplification will have the drug ceritinib added to their treatment regimen as soon as results are available. 

Inclusion Criteria

• Subjects must have a diagnosis of neuroblastoma or ganglioneuroblastoma that meets criteria
• Subjects must be age ≤ 21 years at initial diagnosis
• Subjects must be >12 months of age at enrollment
• Subject's bloodwork must be within acceptable study ranges
• Pregnant subjects are not eligible for this study, a negative serum pregnancy test is required for female participants of childbearing potential
• Both male and female study subjects who have reached puberty must be willing to use a highly effective contraceptive method, these methods will be discussed with you by the study team
• All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.
• Subjects enrolled on study must complete all required assessments 

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Study Description

This trial studies the combination of a study drug called palbociclib with chemotherapy in children with solid tumors that have come back or not responded to standard treatment. Throughout this trial, the study team will observe how the drug is moving through your body and how your body is responding to the drug. The study team will also do a series of tests to study whether or not the drug is effective.

Inclusion Criteria

• Patient must be between 2 years to 20 years old at time of treatment
• Must have measurable disease of a solid tumour that has come back or has not responded to previous standard treatment 
  • For Phase 2 part, must have a diagnosis of Ewing sarcoma specifically 
• Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures related to the study
• Patient must be able to be up and about more than 50% of their waking hours
• For patients of child bearing potential, they must not be pregnant or get pregnant during the course of the study

Other inclusion and exclusion criteria may apply and will be reviewed by your team

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Study Description

This study is to assess the effectiveness of a drug called Difluoromethylornithine (DFMO) in combination with etoposide for patients with neuroblastoma that has come back, or is not responidng to current treatment. DFMO is a medication taken by mouth. It is an blocker of ornithine decarboxylase, an enzyme involved with polyamine biosynthesis in the cancer cells, including neuroblastoma cells. 

Inclusion Criteria

• Patients less than 31 years of age 
• Diagnosis of neuroblastoma that has come back or is not responding to treatment 
• Patients can have active or no active disease at the time of study start
• 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

This study uses a drug called Difluoromethylornithine (DFMO) for patients with neuroblastoma in remission to assess the effectiveness of preventing recurrence. The study also looks at the side effects associated with these medication. DFMO is a medication taken by mouth. It is an blocker of ornithine decarboxylase, an enzyme involved with polyamine biosynthesis in the cancer cells, including neuroblastoma cells. 

Inclusion Criteria

• Patients less than 30 years of age, with high-risk neuroblastoma in complete remission. 

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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.