Canadian clinical trial registry

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Study Description

This study is looking at a new drug called selumetinib to see if it works as well as (or better than) the usual treatment (drugs called carboplatin/vincristine) for children with a type of brain tumor called low grade glioma. This study is also checking if selumetinib is better for helping improve vision for children with these tumors. Selumetinib works by blocking a substance called an enzyme that the tumor cells need to grow, which can help kill them. The regular treatment uses different drugs that stop tumor cells from growing in different ways. This study will compare to see which method is better. 

Inclusion Criteria

• Patients must be >= 2 years and =< 21 years at the time of enrollment
• Patients must have neurofibromatosis type 1 (NF1), newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery
• Additional inclusion criteria applies for patients with optic pathway gliomas, if applicable
• Patient must meet all of the bloodwork and organ function requirements outlined in the study
• Patients with a known seizure disorder should be stable and should have not experienced a significant increase in seizure frequency within 2 weeks prior to enrollment
• Patients must have an adequate performance status 
• Patients must have the ability to swallow whole capsules
• All patients and/or their parents or legal guardians must sign a written informed consent.

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

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Study Description

(As seen on the Australian & New Zealand Childrens Haematology/Oncology Group website - https://anzchog.org/clinic-trails/connect-1903-a-pilot-and-surgical-study-of-larotrectinib-for-treatment-of-children-with-newly-diagnosed-high-grade-glioma-with-ntrk-fusion/ )

Recent research shows that a new oral tablet drug, larotrectinib, has produced promising results by shrinking some solid tumours that have an abnormal or mutated NTRK gene in adults and children.

High grade gliomas (HGG) are fast growing, aggressive brain cancers and if they recur after initial treatment, there are no effective treatment options. This study will investigate if larotrectinib alone as well as Larotrectinib  in combination with chemotherapy or radiotherapy can  be of benefit in children with high grade gliomas with the mutated NTRK gene. This international trial will study how well the drug is tolerated and its effectiveness to shrink these tumours when used alone or when given with standard chemotherapy or after radiation.

Inclusion Criteria

(As seen on the Australian & New Zealand Childrens Haematology/Oncology Group website - https://anzchog.org/clinic-trails/connect-1903-a-pilot-and-surgical-study-of-larotrectinib-for-treatment-of-children-with-newly-diagnosed-high-grade-glioma-with-ntrk-fusion/ )

• Patient must be 21 years old or younger and newly diagnosed with high grade glioma (HGG)
• The tumour must have a genetic anomaly called an NTRK fusion for the patient to qualify
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

The purpose of this study is to test the safety of a cancer drug called repotrectinib in children. The cancer must have a change in a particular gene (ALK, ROS1 or NTRK). Those gene changes lead to abnormal proteins which may cause cancer cells to grow. Repotrectinib blocks the actions of these genes in cancer cells and can therefore be used to treat cancer.

The first study part (Phase 1) is done to determine what dose level of repotrectinib is safe for children, how the drug is absorbed. This phase is now closed.

The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with repotrectinib.

This study is divided into 2 stages/phases.

The first stage or phase evaluates the safety and tolerability of the drug (repotrectinib) in patients with advanced cancers. This allows researchers to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) which can then be used to select the recommended dose for patients. This phase is now closed.

The second stage or phase will determine the effectiveness of the drug (repotrectinib) in treating advanced cancers.

Inclusion Criteria

For the first phase:

• Age <12 years
• Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
• The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

For the second phase:

• Age 12 to less than 25 years
• Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
• The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
• Some patients may be eligible even if they have already received another drug blocking NTRK in the past
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This study seeks to test the effectiveness and best dosage for 2 different combinations of drugs in treating cancers that have come back (recurring) or never completely went away (refractory) after initial treatment. Participants will be randomly assigned to either Arm A or Arm B of the study which will determine the combination of drugs they receive.

In Arm A, participants will receive drugs called Onivyde and talazoparib.

In Arm B, participants will receive drugs called Onivyde and temozolomide.

Both combination of drugs (Onivyde + talazoparib or Onivyde + temozolomide) are expected to irreparably damage the DNA in cancer cells and lead to cancer cell death.

After the best dosages of the drug combinations are determined in Arm A and Arm B, then the study will move on to the next stage called “expansion arms”. These expansion arms treat more participants with the dosages determined in the earlier Arm A and Arm B.

There are 3 expansion arms in this study:

Arm A1: Participants with Ewing sarcoma that has come back (recurring) or never completely went away (refractory) will receive drugs called Onivyde and talazoparib.

Arm A2: Participants with cancers that have come back (recurring) or never completely went away (refractory), and their cancer has a problem with repairing DNA (identified by their doctor) will receive drugs called Onivyde and talozoparib.

Arm B1: Participants with cancers that have come back (recurring) or never completely went away (refractory) will receive drugs called Onivyde and temozolomide.

Inclusion Criteria

• Participants must be > 12 months and <30 years at the time of enrollment
• Diagnosed with cancers that have come back (recurring) or never completely went away (refractory)

• Female or male participant of reproductive potential must agree to use effective contraceptive methods at screening and throughout duration of study treatment.
• Female participants who have begun to menstruate must have a negative urine or serum pregnancy test and must be willing to have additional serum and urine pregnancy tests during the study
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

The purpose of this study is to find out what effects new combinations of treatment will help in treating a cancer called lymphoma. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.

Inclusion Criteria

• Participants must be between 16 to 65 years old to participate
• Participants must have one of the following diagnoses: 
  • Diffuse large cell lymphoma, B-cell (includes primary mediastinal B-cell lymphoma, T-cell rich B-cell lymphoma)
  • Previous indolent lymphoma with transformation to diffuse large B-cell lymphoma at most recent relapse
  • Unclassifiable B-cell lymphoma with indeterminate features between diffuse large B-cell lymphoma and Burkitt lymphoma
• Participants must have the presence of a protein called CD20
• Must meet all bloodwork requirements
• Participants who can bare children must have a negative pregnancy test prior to starting 
• Participants must be willing to sign a consent form and agree to the study schedule

Other inclusion and exclusion criteria may apply and will be discussed with you by the study 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 10 and 25 years
• High Grade Glioma that has come back (relapse) or not improved despite treatment (progression)
• Must meet all bloodwork requirements
• Patient must be up and about at least 60% of their waking hours
• Patient must be willing to comply with study visit requirements and sign a consent form 

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 for children, teens, and young adults who have a type of bone cancer called osteosarcoma. Osteosarcoma is rare but is the most common bone cancer in young people. It happens when cancer cells make immature bone. The study includes participants whose cancer couldn’t be completely removed with surgery and who have shown some improvement or stable disease after regular chemotherapy.

In the study, participants will either:

1. Take a medication called cabozantinib (a daily tablet) along with supportive care, or
2. Receive supportive care only, which can include treatments like antibiotics, nutritional support, pain management, and other care but not cancer-specific therapy.

If the cancer worsens for those receiving only supportive care, they might switch to also taking cabozantinib if they meet certain conditions. Cabozantinib will continue as long as it is helping and well-tolerated. The study is expected to last about 24 months for each participant, but they may stay in the study longer if they are benefiting from the treatment. Participants can choose to leave the study at any time.

Inclusion Criteria

• Participants must be ≥5 and ≤30 years old
• Have a confirmed diagnosis of high-grade osteosarcoma
• Have cancer that couldn’t be fully removed after standard chemotherapy, participants must have had at least 4 cycles of chemotherapy, unless it was stopped early due to side effects.
• Recovered from most side effects of previous treatments (except for hair loss, hearing issues, or mild nerve problems).
• Be able to do most daily activities, and be up and about at least 70% of their waking hours
• Meet organs and bone marrow functioning requirements 
• Have blood pressure under control, with or without medication.
• Follow guidelines for preventing pregnancy if appropriate for their age and situation.
• Sign consent forms: participants 18 or older must sign, and younger participants need a parent or guardian’s consent, plus their agreement if required.

Other inclusion and exclusion criteria may apply and will be discussed with you 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.