Canadian clinical trial registry

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Study Description

If you are a long-distance patient of >160 km, one way - you may be eligible for STEP-1 travel funding. Find more information here. 

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.

NOTE: Enrollment for DIPG and DMG has been discontinued. This study is only opened for patients with HGG without a H3 K27M mutation. 

Inclusion Criteria

Pre-Enrollment

1. Age: Patients must be 25 years old or younger.
2. Diagnosis: Must have a 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. CLOSED
   • HGG: Must be newly diagnosed, without certain genetic mutations. OPEN
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

If you are a long-distance patient of >160 km, one way - you may be eligible for STEP-1 travel funding. Find more information here. 

VICTORY is an early phase study for patients under 25 years who have a type of brain tumor called low grade glioma (LGG) that coms back or gets worse (recurrent or progressive). To participate on this study, the LGG must have certain genetic changes called CRAF or BRAF alterations.

The study has two parts:

Phase A: We are figuring out the best dose of a combination of two medicines, vinblastine and tovorafenib. Patients will take these medicines for a certain number of months, then just tovorafenib for a few more months. Their progress will be checked regularly with scans.

Phase B: After we find the right dose in Phase A, we'll test how well the combination of these drugs works. Patients will take these medicines for a certain number of months, then just tovorafenib for a few more months. Their progress will be checked regularly with scans.

Patients will be in the study for about two years unless their tumor gets worse (disease progression), they have bad side effects or they decide to withdrawal from the study.

Inclusion Criteria

• Patients must be less than or equal to 25 years of age at the time of enrollment
• Patient and/or their parent/guardian must sign an informed consent form to be enrolled on study
• Patients must have a diagnosis of low grade glioma (LGG) with a genetic alteration called BRAF or CRAF alteration that has come back (recurrent) or not responded to previous treatment (progressive)
• Patients must have completed at least 1 other therapy prior to enrollment on this study and recovered from its effects.
• Patients must have adequate performance status (daily activities which they are able to do) 
• Must have adequate organ function in bone marrow, kidneys, liver, heart and thyroid
• Willingness of male and female patients with reproductive potential to use double effective birth control methods, defined as one used by the patient and another by his/her partner, for the duration of treatment and for 180 days following the last dose of study drug. 
• Ability to swallow tablets or liquid, or gastric access via a nasal or gastric tube.

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

This study is for children, teens and young adults whose solid tumors have come back or didn’t respond to treatment. It tests two different medicine combinations, and each person is randomly placed into one of two groups. Arm A uses drugs called Onivyde and talazoparib, and Arm B uses Onivyde and temozolomide. The first part of the study focuses on finding the safest doses and has now been completed. Once the safest doses are found, more patients can join “expansion arms” to see how well the treatments work, including groups for those with certain DNA-repair problems. Phase II is now open for patients with Ewing sarcoma, who will also be randomly assigned to Arm A or Arm B to test the same medicine combinations.

Inclusion Criteria

• Participants must be > 12 months and <30 years old at the time of enrollment
• Must have a type of solid tumor that has come back or not responded to treatment
• For Ewing sarcoma patients: the cancer must have come back or not responded to first treatment, and must have a confirmed EWS-related gene change
• Must be up and about at least half of waking hours
• Must meet all organ function and bloodwork requirements
• Enough time must have passed since the last doses of chemo, growth factors, biologics, radiation or other treatments
• Anyone able to have children must use effective birth control during the study. Patients who could become pregnant must have a negative pregnancy test confirmed. 
• Parent/guardian and patient (if assessed to have capacity) must sign consent

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

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Study Description

This study is evaluating a medication called blinatumomab that is given as an injection under the skin to treat B-cell acute lymphoblastic leukemia (B-ALL) that has come back after treatment or has not responded to previous therapy. The first part of the study will focus on finding the safest and most appropriate dose, while the second part will look more closely at how well the treatment works and how safe it is in participants aged 12 years and older. The study will include people whose leukemia has returned, has not responded to treatment, or who still have a very small number of leukemia cells remaining after treatment. Researchers will also study how the medication moves through and is processed by the body.

Inclusion Criteria

• Participants must be 12 Years and older. Additional age restrictions may apply for specific arms of this study. 
• Must have a diagnosis of B-precursor Acute Lymphoblastic Leukemia (ALL) that has come back after treatment or has not responded to previous therapy.
• Must meet bone marrow blast and function requirements
• Must be up and about at least 50% of waking hours

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 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 is a research study combining an oral drug called mirdametinib with an intravenous chemotherapy drug called vinblastine for the treatment of patients with pediatric low grade glioma with certain mutations. 

In this first part, doctors will carefully test different dose levels of the two medicines to find the safest and most appropriate dose to use in the next phase. Patients will take mirdametinib by mouth twice a day at a set dose for 13 treatment cycles (each cycle is 28 days). They will also receive vinblastine through an IV once a week for 17 cycles. If side effects happen, the dose can be lowered up to two times to keep treatment safe. After treatment ends, patients will come back for check-ups every 6 months for 3 years. These visits help doctors track how the tumour responds over time and how patients are doing overall.

Inclusion Criteria

• A parent or substitute decision maker (or the participant if they have capacity) must sign a consent form before joining the study
• Participants need to be able to come to scheduled appointments, take study medicines as instructed, complete lab tests, and have MRIs as part of their care
• Participants must be between 2 and 25 years old when starting mirdametinib.
• Participants must have a type of low-grade brain tumour (PLGG) with one of the following:
  • An NF1 gene change (based on medical criteria or genetic testing), or
  • A KIAA1549-BRAF fusion, or
  • Another MAPK pathway change, except for the BRAF V600E mutation.
• Tumour tissue is needed for testing (usually a stored tissue block, and fresh frozen tissue if available).
  • Children with NF1 and low-grade glioma can still join even if they never had surgery or a biopsy.
• A recent MRI before starting 
• Must be well enough to take part in daily activities at least 50% of waking hours
• Organ and bone marrow function and body surface area must be within allowable limits
• Teens and adults who could become pregnant must use effective birth control during the study
• Must be able to swallow the medication by mouth, as this drug cannot be given through feeding tubes

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

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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.