Canadian clinical trial registry

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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 study to find out whether a drug called olaparib (also called a PARP inhibitor) is safe and well tolerated when administered to children and adolescents with solid tumours or brain tumours, when they have come back or are not improving with treatment.

Inclusion Criteria

• Patients are ≥ 6 months to <18 years of age 
• Patients have a solid tumour or brain tumour that has come back (relapsed) or is not improving with treatment (refractory)  
• There is a gene change in the tumour or in the normal cells of the patient that can be called "homologous recombination repair gene mutation"
• The patient can swallow tablets
• Multiple other inclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This phase III trial compares the effect of two chemotherapy drug pathways (vinorelbine with vincristine, dactinomycin, and cyclophosphamide (VAC) followed by vinorelbine and cyclophosphamide versus VAC followed by vinorelbine and cyclophosphamide) for the treatment of high risk rhabdomyosarcoma.

Chemotherapy drugs, such as vinorelbine, vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Giving vinorelbine and VAC may kill more tumor cells and adding maintenance therapy after VAC therapy may help get rid of the cancer and/or lower the chance that the cancer comes back.

Inclusion Criteria

• Patients must be =< 50 years of age 
• Study is open to all genders
• Patients with newly diagnosed rhabdomyosarcoma (RMS) of any subtype, meeting "high risk" criteria
• Various bloodwork (bilirubin, creatinine, etc) must be within an acceptable range
• Patients must not be pregnant during the duration of the trial
• Additional inclusion and exclusion criteria may apply and will be reviewed by the study team

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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 study is to test the safety of a drug called lurbinectedin in solid tumours that have come back (relapsed) or not responded to treatment (refractory). It is conducted in 2 parts, Phase 2 will further assess this drug in participants with Ewing sarcoma specifically.

Inclusion Criteria

• Participant must meet the following age requirements:
  • Phase 1 Part 1: participants must be ≥ 2 to < 18 years of age.
  • Phase 1 Part 2: participants must be ≥ 2 to ≤ 30 years of age.
  • Phase 2: participants must be ≥ 2 to ≤ 30 years of age.
• Participant has a confirmed solid tumor (For phase 2, Ewing Sarcoma)
• The participant is up and about for more than half their waking hours
• Participant meets all lab value requirements during the screening period
• Participant weighs at least 15kg
• Must not be pregnant (if applicable), and/or must be on an acceptable birth control method 
• Must sign informed consent and agree to attending all required study assessments 

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

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Study Description

The purpose of this study is to evaluate the safety and efficacy of combining Focused Ultrasound (Exablate Model 4000 Type 2.0/2.1) with Doxorubicin therapy for the treatment of DIPG in pediatric patients.

Inclusion Criteria

• Age between 5 and 18 years, inclusive
• Patient diagnosed with DIPG
• Must be between 4-12 weeks from completion of radiation therapy
• Able to attend all study visits
• Able and willing to give consent and/or assent or have a legal guardian who is able and willing to do so
• If brain surgery occurred, at least 14 days passed since last brain surgery and the patient is fully recovered and neurologically stable

Additional inclusion and exclusion criteria may be discussed with you by the study team.

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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 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