Canadian clinical trial registry

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Study Description

Some neuroblastoma have a specific genetic change or mutation called an ALK aberration.  ALK, or anaplastic lymphoma kinase, has been found in several adult and pediatric cancers.  ALK aberrations are present in about 14% of newly diagnosed patients with high-risk neuroblastoma, and can be found more frequently at the time of relapse.  Lorlatinib is a drug called an ALK inhibitor. It is expected to slow or stop the growth of cancer cells which have the ALK aberration. The aim of this phase I/II study is to evaluate the dose, safety, and tolerability of lorlatinib, including the effect it has on the cancer.  Lorlatinib will be given alone or in combination with chemotherapy in children with refractory, relapsed or progressive neuroblastoma with ALK alterations.

Inclusion Criteria

• Patients must have a diagnosis of neuroblastoma either by histologic verification (looking at a sample of the tumour under a microscope) of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines (HVA/VMA).
• Patients are required to have an activating ALK aberration in their tumor, which is identified through genetic testing.
• Patients must have high risk neuroblastoma. Patients who were initially considered low or intermediate risk, but then reclassified as high risk are also eligible.
• Patients must have at least ONE of the following: 1) Recurrent/progressive disease at any time prior to study enrollment, 2) Refractory disease, 3) Persistent disease

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 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 is a phase I/II trial that studies how well the treatments tiragolumab and atezolizumab work when given to children with tumours that have either come back (relapsed) or did not respond to therapy (refractory). These tumours must have a certain mutation, meaning the cancer cells are missing important genes called SMARCB1 and SMARCA4. Tiragolumab and atezolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Inclusion Criteria

• Participants must be between 1-18 years old for part A of this study. There is no upper age limit for part B
• Participants must have one of the following cancers, that has either come back (relapsed) or did not respond to previous treatment (refractory):
  • Renal medullary carcinoma
  • Malignant rhabdoid tumor (extra-CNS)
  • Atypical teratoid rhabdoid tumor (CNS)
  • Poorly differentiated chordoma
  • Epithelioid sarcoma
• Cancer must have the eligible mutation (SMARCB1 or SMARCA4)
• Participants must be up and about for at least half their waking hours
• Participants must meet all bloodwork criteria outlined for this study

Other inclusion and exclusion criteria may apply and will be discussed with you by your clinical team

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Study Description

This phase I/II trial tests the safety, best dose, and whether elimusertib works in treating patients with solid tumors that have come back (relapsed) or does not respond to treatment (refractory). Elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Inclusion Criteria

• Age Restrictions: 
  • Part A:
    • Patients between >= 12 months and < 18 years of age
  • Part B:
    • Patients between >= 12 months and =< 30 years of age for the phase 2 expansion cohorts for both EWS and PAX3-FOXO1 ARMS.
    • Patients between >= 12 months and =< 21 years of age for the phase 2 DDR expansion cohort
• Patients must be able to swallow tablets of the study drug (elimusertib)
• Patients must have a solid tumor diagnosis that has come back (relapsed) or has not respond to treatment (refractory)
  • NOTE: further restrictions may apply for each cohort and will be discussed with you by the clinical team
• Patients must have measurable disease
• Patients must be up and about at least half of their waking hours
• Bloodwork requirements must be met prior to treatment
• Patients must meet the minimum duration from any prior anti-cancer therapy before enrolling. These timelines will be discussed with you by the clinical team.  
• Patients or their substitute decision maker must sign a consent form and agree to the required study assessments

Additional inclusion and exclusion crieria may apply 

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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 clinical trial studies the side effects of a medication called CLR131. This medication is a targeted radiopharmaceutical, which means it acts like radiation therapy, but is given intravenously as an infusion. 

CLR 131 is designed to target cells with cancer rather than cells without cancer. The main goal of this study is to determine what is the safe amount of medication to give to children with cancer that has come back or is not responding to treatment.

Inclusion Criteria

• Age between 2 and 25 years
• All cancers (except leukemia) that have come back (relapse) or not improved despite treatment (progression)
• Patients need to undergo blood stem cell collection or have those cells available from a previous collection
• 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

Philadelphia-like leukemia has specific genetic changes. This study is to assess the dose and effectiveness of an oral medication called ruxolitinib that targets Philadelphia-like leukemia cells. It blocks a protein called JAK. The medication is given in addition to standard therapy for the leukemia. 

Based on the leukemia genetics and initial response to treatment, patients are divided into 4 groups. 

Inclusion Criteria

• Patients between 1 and 21 years of age
• New diagnosis of Philadelphia-like, high-risk B-cell acute lymphoblastic leukemia
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team