Canadian clinical trial registry

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Study Description

Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and some patients who relapse following CD19 directed therapy relapse with CD19 negative leukemia. For this reason, the investigators are attempting to use T-cells obtained directly from the patient, which can be genetically modified to express two chimeric antigen receptors (CARs). One is to recognize CD19 and the other is to recognize CD22, both of which are proteins expressed on the surface of the leukemic cell in patients with CD19+CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through recognition of CD19 and CD22. This is a phase 1 study designed to determine the safety of the CAR+ T-cells and the feasibility of making enough to treat patients with CD19+CD22+ leukemia.

Inclusion Criteria

• First 2 subjects: male and female subjects age ≥18 and < 27 years (as of 2/16/18 the first 2 subjects were enrolled and treated); subsequent subjects: male and female subjects age ≥12 months of age and <27 years.
• Diagnosis of CD19+22+ leukemia relapsed or refractory
• Asymptomatic from CNS involvement
• Free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks prior to enrollment
• Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy
• No prior genetically modified cell therapy that is still detectable or virotherapy
• Willing to participate in long-term follow-up for up to 15 years, if enrolled in the study and receive T cell infusion

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 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

Part A is now completed, Part B criteria now applies: 

• 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 study evaluates how effective a drug called plixorafenib is in participants with solid tumors or central nervous system (CNS) tumors with a genetic mutation called a BRAF fusion/BRAF V600E mutation that have progressed or come back.

Inclusion Criteria

• Male and female, ≥10 years of age, and weighing ≥30 kg.
• Diagnosis of a solid tumor or primary CNS tumor that has previously been treated with other standard therapies
• Documentation of BRAF gene fusion in tumor
• Willingness to provide informed consent and comply with study requirements 

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

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Study Description

This clinical trial is testing a new treatment for children and young adults with aggressive brain tumors, including DIPG and high grade glioma with a specific genetic change (H3 K27M mutation). The treatment combines standard radiation therapy with a new medicine called selinexor, which may help stop cancer cells from growing and shrink tumors. Patients receive radiation for 5-7 weeks and take selinexor pills weekly during and after radiation for up to two years. The study will first find the safest dose of selinexor and then test how well it works. MRIs and follow-up visits help monitor progress. Researchers hope this treatment will improve outcomes for these difficult-to-treat brain tumors.

Inclusion Criteria

Pre-Enrollment

1. Age: Patients must be 25 years old or younger.
2. Diagnosis: Must have a suspected or confirmed diagnosis of DIPG or newly diagnosed high-grade glioma (HGG) that hasn’t spread.
3. Consent: A parent or guardian, or the patient, must sign a consent form.
4. Samples (non-DIPG tumours): Tumour samples from surgery or biopsy need to be submitted soon after the procedure (ideally within 5 days).

Main Enrollment

1. Age: Patients must be between 1 and 21 years old.
2. Diagnosis:
   • DIPG: Must meet specific imaging or biopsy criteria.
   • HGG: Must be newly diagnosed, without certain genetic mutations.
3. Patients need to be in good overall health with normal lab results and no severe symptoms.
4. Enrollment must happen within 31 days of diagnosis or surgery.
5. A signed consent form is required.

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

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Study Description

This is a study of a new oral medication called gilteritinib, to be given in combination with chemotherapy to patients that have acute myeloid leukemia that has come back (relapse). The leukemia cells need to have a genetic change called "FLT3 ITD" for the patient to be considered for the study. Gilteritinib is an anti-cancer medication that blocks the FLT3 protein when it is abnormal in a leukemia cell.

The main goal of the study will be to establish an optimally safe and biologically active dose of the medication, and then to determine the effect it has on leukemia disease in combination with chemotherapy.

Inclusion Criteria

• Age from 6 months to 21 years
• Acute myeloid leukemia that has come back (relapse) and has a genetic change called "FLT3 ITD"
• 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 3 study for patients with newly diagnosed diffuse glioma. To be eligible for this study, the participant's cancer must have a mutation called H3 K27M. This study explores whether adding treatment with the experimental drug called ONC201 after radiotherapy is effective in patients with this type of cancer. 

Inclusion Criteria

• Able to understand the study procedures and agree to participate in the study by providing written informed consent and assent when applicable.
• Body weight ≥ 10 kg
• A new diagnosis of diffuse glioma with a H3 K27M mutation 
• Received frontline radiotherapy (radiation) within 2-6 weeks of starting this study
• Patient must be capable of self-care but may be unable to engage in normal activities or perform active work

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

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Study Description

In this study, researchers are trying to learn more about the safety of the combination of study medicines Avelumab and Lenvatinib, and how well they work for children and young people with central nervous system tumours where previous treatment have not worked.

If you/your child participate in this study, you/they will be asked to join one of the two parts.

Part 1 will help us learn the best dose of the drug to take, and in Part 2, we will use the information obtained in Part 1 to continue to give the study drug and monitor how it is working.

Inclusion Criteria

• Patients must have a confirmed diagnosis of a high-grade brain tumour
• Patients must be between the ages of 2-18 years old
• Patients must have a cancer that has come back (relapsed) after a previous treatment
• Patients must be able to walk and do routine activities for more than half of their normal waking hours
• Patients must have a willingness to complete clinical assessments throughout the study (electronic, paper and/or interviewer methods)

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

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Study Description

This phase 2 trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT-driven medulloblastoma.

(via: https://childrensoncologygroup.org/acns1422)

Inclusion Criteria

• Patients are between 3 years to 21 years old
• Patient is newly diagnosed with average-risk medulloblastoma  in the WNT subgroup by institutional diagnosis
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.