Canadian clinical trial registry

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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

99 results found

Title
Status

 

U-R-Immune - U-R-Immune Glioma (CA209-1245): A Pilot Study Investigating Upfront Adaptive Immunotherapy Approach in Children, Adolescent and Young Adult (CAYA) Patients With Replication-Repair Deficient (RRD) High-Grade Gliomas (HGG)

Open

U-R-Immune - U-R-Immune Glioma (CA209-1245): A Pilot Study Investigating Upfront Adaptive Immunotherapy Approach in Children, Adolescent and Young Adult (CAYA) Patients With Replication-Repair Deficient (RRD) High-Grade Gliomas (HGG)

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DiagnosisHigh Grade Glioma, Replication Repair DeficientStudy StatusOpen
PhaseN/A
Age12 Months to 25 YearsRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationDrug: Nivolumab All patients will be administered Nivolumab with or without radiation
Last Posted Update2024-12-12
ClinicalTrials.gov #NCT06519682
International Sponsor
The Hospital for Sick Children
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Uri Tabori
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

 This study is eligible for STEP-1 funding. Find more information here

 This study is eligible for STEP-1 funding. Find more information here

 

This study is testing a medicine called nivolumab for people with a type of brain cancer called RRD-glioblastoma. The goal is to see if this medicine can help delay or avoid the need for radiation treatment.

 

Inclusion Criteria
  • Patient must be between 1 and 25 years old.
  • Must have glioblastoma, confirmed by a biopsy
  • Tumor must show certain genetic changes linked to RRD, confirmed by tests on the tumour
  • A sample of the tumor is needed for analysis, and another sample may be required if the tumor grows back
  • Most or all of the tumor must have been removed in surgery, and treatment should start within 4 weeks after surgery.
  • No treatments (like chemotherapy or radiation) for glioblastoma are allowed before the study, but surgery is okay. Past treatment for other cancers is allowed if previous cancer is in remission
  • Must have good overall health, including healthy organs and no serious infections
  • Participants and their families must agree to join the study

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

PBTC-045 - A Safety and Preliminary Efficacy Trial of Pembrolizumab (MK-3475) in Children With Recurrent, Progressive or Refractory Diffuse Intrinsic Pontine Glioma (DIPG), Non-Brainstem High-Grade Gliomas (NB-HGG), Ependymoma, Medulloblastoma or Hypermutated Brain Tumors

Closed

PBTC-045 - A Safety and Preliminary Efficacy Trial of Pembrolizumab (MK-3475) in Children With Recurrent, Progressive or Refractory Diffuse Intrinsic Pontine Glioma (DIPG), Non-Brainstem High-Grade Gliomas (NB-HGG), Ependymoma, Medulloblastoma or Hypermutated Brain Tumors

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DiagnosisHigh-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas, Hypermutated Brain Tumors, Ependymoma, MedulloblastomaStudy StatusClosed
PhaseI
Age1 Year to 29 Years RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Pembrolizumab (IV over 30 minutes)
Last Posted Update2024-12-12
ClinicalTrials.gov #NCT02359565
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Vijay Ramaswamy
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

The purpose of this research study is to investigate an experimental drug, MK-3475 (also called pembrolizumab), in young patients. The drug MK-3475 has been previously studied in adults, in a variety of tumors, but is not yet FDA approved. The first phase is a safety study to assess side effects and best dose of pembrolizumab, the second phase is the efficacy portion to see how well it works in treating childhood brain tumors that have come back (recurrent), progressed, or not responded (refractory) to previous treatment. 

(transcribed from PBTC-045 Summary for Patients and Families)

Inclusion Criteria
  • Patient must have one of the following diagnoses that have come back, progressed or not responded to treatment, to be eligible: 
    • Stratum A : DIPG - currently closed to enrollment
    • Stratum B : Non-brainstem high-grade glioma (NB-HGG)
    • Stratum C : Hypermutated brain tumor
    • Stratum D : Ependymoma
    • Stratum E : Medulloblastoma 
  • Patient must have been treated with prior radiation therapy and/or chemotherapy (exclusions apply)
  • Both males and females of all races and ethnic groups are eligible for this study
  • Patient must be able to be up and about more than 50% of their waking hours
  • Age Requirements:
    • Stratum A  -  1 year to 18 years old during safety portion, <22 years during efficacy, currently closed to enrollment
    • Stratum B  - 1 year to 18 years old during safety portion, <22 years during efficacy
    • Stratum C  - Younger than 30 years old
    • Stratum D  - 1 year to 18 years old during safety portion, <22 years during efficacy
    • Stratum E  - 1 year to 18 years old during safety portion, <22 years during efficacy
  • Patients must have satisfactory blood work prior to enrolling
  • Patient must not have any shortness of breath
  • Human immunodeficiency virus (HIV)-infected patients with undetectable viral load within 6 months are eligible for this trial
  • Patients of child bearing potential must NOT be pregnant, and must agree to use 2 methods of birth control, be surgically sterile, or abstain from heterosexual activity while on study and 6 months after
  • Patient and/or guardian must sign a written consent document

Additional inclusion and exclusion criteria may apply.

CONNECT1903 - A Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly-Diagnosed High-Grade Glioma with NTRK Fusion

Open

CONNECT1903 - A Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly-Diagnosed High-Grade Glioma with NTRK Fusion

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DiagnosisHigh Grade Glioma Study StatusOpen
PhaseII
AgeChild, Adult - (up to 21 Years) RandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationOral
Last Posted Update2024-10-10
ClinicalTrials.gov #NCT04655404
International Sponsor
Nationwide Children's Hospital
Principal Investigators for Canadian Sites
Montreal Children’s Hospital – Dr. Geneviève Legault
The Hospital for Sick Children - Dr. Uri Tabori
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 

 

 

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

STEP-RB - Phase I Sustained-Release Topotecan Episcleral Plaque (Chemoplaque) for Retinoblastoma

Closed

STEP-RB - Phase I Sustained-Release Topotecan Episcleral Plaque (Chemoplaque) for Retinoblastoma

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DiagnosisRetinoblastoma Study StatusClosed
PhaseI
AgeChild - (up to 17 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationTopotecan - administered using an episcleral plaque (chemoplaque), an implant which contains topotecan (drug). The implant is attached to the outside of the eye and delivers topotecan directly into the eye.
Last Posted Update2024-10-03
ClinicalTrials.gov #NCT04428879
International Sponsor
The Hospital for Sick Children
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This clinical trial studies the side effects and how well a chemoplaque with topotecan (a medication attached to the outside of the eye) works in treating patients with retinoblastoma. This plaque has to be installed and removed under general anesthesia by the ophthalmology team. It delivers the chemotherapy inside the eye.

Inclusion Criteria
  • Age up to 18 years
  • Retinoblastoma in at least one eye
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

CONNECT2108 - Phase 2 Study of the MEK Inhibitor MEKTOVI® (Binimetinib) for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

Open

CONNECT2108 - Phase 2 Study of the MEK Inhibitor MEKTOVI® (Binimetinib) for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

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DiagnosisAdamantinomatous CraniopharyngiomaStudy StatusOpen
PhaseII
Age1 Year to 25 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Binimetinib Oral Tablet [Mektovi]
Last Posted Update2024-09-19
ClinicalTrials.gov #NCT05286788
International Sponsor
Nationwide Children's Hospital
Principal Investigators for Canadian Sites
CHU Ste Justine - Dr Sébastien Perreault
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

MEKTOVI (binimetinib) is a medicine taken by mouth that helps block certain signals in the body that make some tumors grow. In this Phase II study, the drug will be used to treat children diagnosed with Adamantinomatous Craniopharyngioma (ACP), a type of brain tumor. This tumor can be very challenging to treat, and current options like surgery and radiation can affect the patient's quality of life, especially when the tumor comes back.

Recent research shows that ACP might respond to medicines like binimetinib that block specific pathways in the body.

Up to 38 children will take binimetinib in pill form, twice a day for 4 weeks (1 cycle), and treatment could continue for up to two years. The trial will include children aged 1 to 25, some of whom have already had radiation therapy.

The goal is to see if this medicine can help control the tumor and improve their quality of life.

Inclusion Criteria
  • Patients must be between 1 and 25 years old.
  • Must have a confirmed Adamantinomatous Craniopharyngioma (ACP), either from a solid tumor or cyst fluid.
  • Must have a measurable tumor that can be seen on scans:
    • Stratum 1: Patients whose tumor came back or got worse at least 6 months after finishing radiation therapy.
    • Stratum 2: Patients who have had surgery but have not had radiation (they may have had other treatments before).
  • Patients must be able to do at least half of their usual activities, even if they use a wheelchair.
  • Must have recovered from any side effects of previous treatments.
  • Previous Treatments:
    • At least 7 days since the last dose of any biologic treatment (anti-tumor therapy).
    • At least 42 days since any immunotherapy (e.g. cancer vaccines).
    • At least 21 days since a monoclonal antibody treatment.
    • At least 6 months since focused radiation and no history of radiation to the whole brain/spine.
    • Corticosteroids: If on dexamethasone, the dose must be stable or reducing for at least 1 week.
    • Chemotherapy: At least 21 days since the last round of chemotherapy.
    • Surgery: At least 6 weeks since any surgery.
  • Blood counts and organ function requirements must meet certain safety levels before treatment.
  • Patient and/or their parent/guardian must agree to join the study by signing a consent form.

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

Publications

ARET2121 - Intravitreal Melphalan for Intraocular Retinoblastoma

Open

ARET2121 - Intravitreal Melphalan for Intraocular Retinoblastoma

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DiagnosisBilateral Retinoblastoma, Childhood Intraocular Retinoblastoma, Group D Retinoblastoma, Stage I Retinoblastoma, Unilateral RetinoblastomaStudy StatusOpen
PhaseII
Ageup to 18 YearsRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationCVE (Carboplatin/Vincristine/Etoposide - given intravenous (IV) Melphalan - intravitreal (injection in eye)
Last Posted Update2024-09-19
ClinicalTrials.gov #NCT05504291
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
CHU Ste. Justine - Dr. Monia Marzouki
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

This trial is looking at whether adding a medicine called melphalan (which is injected into the eye) to regular chemotherapy can help treat children with retinoblastoma, a type of eye cancer. Retinoblastoma can sometimes be harder to treat when there are tiny bits of the tumor floating in the jelly-like part of the eye - called vitreous seeds. Melphalan, along with other chemotherapy drugs, works by stopping cancer cells from growing and dividing. The goal of this study is to see if adding melphalan early in treatment can better target those floating tumor bits and improve treatment for retinoblastoma.

Inclusion Criteria
  • Must be under 18 years old
  • The child must have a new diagnosis of retinoblastoma (a type of eye cancer) that is still in the eye 
  • Participant must meet one of the following conditions: 
    • Retinoblastoma in one eye (Group D) with tumor pieces floating in the eye fluid.
    • Retinoblastoma in both eyes, with one eye in Group D (with tumor pieces in the fluid) and the other eye less severe (Group A-C).
    • Retinoblastoma in both eyes, with at least one eye in Group D (with tumor pieces in the fluid).
    • Retinoblastoma in both eyes, with one eye in Group D (with tumor pieces in the fluid) and the other eye in Group E (most severe), where the Group E eye was removed before any treatment.
    • Retinoblastoma in both eyes, with one eye in Group D (with tumor pieces in the fluid) and one Group E eye that hasn't been removed yet (depending on the doctor's decision).
  • The child must be in good enough health to handle treatment, based on performance scores for their age.
  • Blood counts and kidney function must meet certain safety levels before treatment.

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

BLU-285-3101 - A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling

Closed

BLU-285-3101 - A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling

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DiagnosisSolid Tumor, Relapsed Solid Neoplasm, CNS TumorStudy StatusClosed
PhaseI/II
Age2 Years to 17 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: avapritinib (Route: Oral) Other Name: BLU-285
Last Posted Update2024-09-18
ClinicalTrials.gov #NCT04773782
International Sponsor
Blueprint Medicines Corporation
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This is a phase 1/2 study that studies the drug avapritinib in patients 2-17 years old with solid tumors that have come back (relapsed) or have not responded to previous treatment (refractory). The tumor must have a certain genetic mutation (in KIT, PDGFRA or H3K27M (glioma only)) to qualify you for the study. The study consists of 2 parts; in part 1, more information will be gathered about the drug's safety and how it moves through the body (pharmacokinetics or PK) and in part 2, the effectiveness, safety and PK will continued to be monitored at the recommended dose. 

Inclusion Criteria
  • Patients must be between 2-17 years old
  • Patients must have a diagnosed solid or central nervous system (CNS) tumor that has progressed despite prior standard therapy or no alternative treatment is available 
  • Patients must be able to be up and about at least half of their waking hours (if applicable)
  • Blood work must come back within acceptable ranges within 14 days of the first study dose
  • Patients must not be pregnant on the trial, participants of child bearing potential must agree to use approved contraception methods
  • Patients and/or their families/caregivers must sign a consent form outlining all assessments and requirements

PBTC-059 - Phase 1 Trial of Autologous HER2-specific CAR T Cells in Pediatric Patients With Refractory or Recurrent Ependymoma

Open

PBTC-059 - Phase 1 Trial of Autologous HER2-specific CAR T Cells in Pediatric Patients With Refractory or Recurrent Ependymoma

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DiagnosisEpendymomaStudy StatusOpen
PhaseI
Age1 Year to 22 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationBiological: HER2 Specific CAR T Cell (IV) Phase 1 Arm: Patients receive lymphodepletion chemotherapy with cyclophosphamide IV daily on Days -7 to -6 and fludarabine IV daily on Days -5 to -1. Patients receive HER2 CAR T cells IV on Day 0. Treatment repeats every 8 to 12 weeks for 2 additional cycles in the absence of disease progression or unacceptable toxicity. Surgical Arm: Patients receive lymphodepletion chemotherapy with cyclophosphamide IV daily on Days -7 to -6 and fludarabine IV daily on Days -5 to -1. Patients receive HER2 CAR T cells IV on Day 0 followed by surgical tumor resection 4-6 weeks following HER2 CAR T cell infusion. Treatment repeats every 8 to 15 weeks for 2 additional cycles in the absence of disease progression or unacceptable toxicity.
Last Posted Update2024-09-13
ClinicalTrials.gov #NCT04903080
International Sponsor
Pediatric Brain Tumor Consortium
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Joerg Krueger
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This study evaluates the safety of a type of treatment called HER2 CAR T cells (short for HER2 chimeric antigen receptor T cells). In addition to looking for side effects, we will study how well this treatment works against a brain tumor called ependymoma that has come back after treatment (recurrent) or has not responded well to treatment (progressive) in children. The HER2 CAR T cells used in this trial are made from the patient's own blood.

A new gene, called the HER2 CAR, will be inserted into patient's cells to allow them to recognize a protein on the tumor called HER2. These HER2-specific CAR T cells may be able to target and kill ependymoma tumors. This research is also studying how doable it is to provide this type of CAR T cell treatment to children being treated at different hospitals.

Inclusion Criteria
  • Participants must have a diagnosis of ependymoma that is has come back or progressed.
  • Patient must be ≥ 1 but ≤ 22 years of age at the time of enrollment for treatment.
  • Participants must be up and about for 60% of their waking hours
  • Patients must have received last dose of previous chemotherapy at least 21 days before enrollment.
  • Patient must meet all organ function, bone marrow function and laboratory criteria
  • The patient or parent/guardian can understand the consent and is willing to sign a written informed consent document according to institutional guidelines. Age- and developmentally appropriate assent should be obtained as required by institutional guidelines.

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