Registre canadien des essais cliniques

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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. 

A pilot study to see if it is possible and safe to add medicine given into the spinal fluid (intrathecal chemotherapy) and continued treatment (maintenance therapy) after strong chemotherapy for young children under 6 years old who have newly diagnosed high-risk brain tumors.

Inclusion Criteria

• Age: Children 6 years old or younger at the time their brain tumor is confirmed.
• Tumor types: Certain rare, aggressive brain or spinal tumors, including ATRT, medulloblastoma (group 3 or 4), pineoblastoma, ETMR, and other similar embryonal brain tumors.
• MRI scans: MRI of the brain and spine (with and without contrast) must be done before and after surgery.
• Lumbar puncture (spinal tap): A sample of spinal fluid is recommended (if safe to do) before or after surgery, but not required.
• Must meet all lab and organ function requirements
• Must be well enough to 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

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

Researchers are looking for new ways to treat children with hepatoblastoma or rhabdomyosarcoma (RMS) that has come back or not responded to other treatment. This study treatment investigating whether HER3-DXd (also known as MK-1022 or patritumab deruxtecan) is safe, effective and how it is absorbed. 

Inclusion Criteria

• Children and teens (between 1 month to 17 years old) with one of these cancers: hepatoblastoma or rhabdomyosarcoma
• The cancer must have come back or not responded to treatment
• Participants must have already tried at least one treatment before and don’t have another good standard option left.
• Side effects from past treatments should be mild or gone
• Children who had hepatitis B or C can join if the virus is under control with medicine and no virus is showing up in tests.

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 eligible for STEP-1 funding. Find more information here. 

This study is testing Opdualag, a medicine that combines two drugs, in children, teens, and young adults (12 years and older) whose cancers have returned or not responded to treatment. Some participants will have tumors that show high immune activity, while others will have tumors that did not respond to previous immunotherapy.

The study will look at how well Opdualag works, any side effects, and how treatment affects quality of life. Blood and tissue samples will also be collected to help researchers better understand the cancer and the immune system.

Inclusion Criteria

• Patients must be 12 years or older with cancer that has come back or didn’t respond to treatment.
• Patients have a cancer (outside or inside the brain/spine) that has come back or not responded to treatment
• There are two groups:
  • Tumors with a strong immune response
  • Tumors with a DNA repair problem has worsened during or after prior immunotherapy
• Patients must have measurable disease confirmed by appropriate imaging methods
• Must meet all organ function requirements
• Must be up and about at least 50% of waking hours (wheelchair allowed)
• Enough time must have passed from any previous treatment; the study team will let you know the timelines
• Patients must remain abstinent or use adequate birth control as explained 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.