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.

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

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

SNDX-5613-0700 - AUGMENT-101: A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX 5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Closed to enrollment

SNDX-5613-0700 - AUGMENT-101: A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX 5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

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DiagnosisAcute Myeloid Leukemia Acute Lymphoblastic Leukemia Mixed Lineage Acute Leukemia Mixed Phenotype Acute Leukemia Acute Leukemia of Ambiguous LineageStudy StatusClosed to enrollment
PhaseI/II
Ageup to 18 YearsRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: SNDX-5613 (given orally) Drug: Cobicistat (Patients in Phase 1 Arm C patients will receive 150 mg cobicistat daily)
Last Posted Update2024-09-11
ClinicalTrials.gov #NCT04065399
International Sponsor
Syndax Pharmaceuticals
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Jim Whitlock
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 I/II study that studies the drug SNDX-5613 in patients with acute leukemia. In phase 1, the dose will be increased to find the maximum tolerated dose of SNDX-5613 and the recommended dose for the next phase will be determined. In phase 2, patients will be given the recommended phase 2 dose determined in phase 1, and the safety and efficacy in patients with various tumour mutation will be studied. 

Inclusion Criteria
  • Patients must have active acute leukemia with certain genetic characteristics
  • Patients must be over 30 days old 
  • Patients must be up and about more than 50% of waking hours (if applicable)
  • Adequate time must have passed from all previous treatments (i.e at least 60 days must have passed from last radiation treatment/stem cell infusion (if applicable))
  • Adeqaute organ function
  • Blood work must come back within acceptable ranges
  • Patients of child bearing potential must be willing to use a highly effective method of contraception from the time of enrollment to 120 days after the last study drug dose
  • Patients and/or their families/caregivers must sign a consent form outlining all assessments and requirements

ReRAD - A Phase II Canadian Pediatric Brain Tumour Consortium Study of Re-Irradiation as Treatment of Progressive or Recurrent Diffuse Intrinsic Pontine Glioma

Closed to enrollment

ReRAD - A Phase II Canadian Pediatric Brain Tumour Consortium Study of Re-Irradiation as Treatment of Progressive or Recurrent Diffuse Intrinsic Pontine Glioma

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DiagnosisRecurrent or Progressive Diffuse Intrinsic Pontine GliomaStudy StatusClosed to enrollment
PhaseII
AgeChild - (up to 17 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationPatients will receive 30.6 Gy or 36 Gy of a second course of radiation therapy for progressive or recurrent DIPG
Last Posted Update2024-09-11
ClinicalTrials.gov #NCT03126266
International Sponsor
University of Calgary
Principal Investigators for Canadian Sites
Alberta Children’s Hospital - Dr. Lucie Lafay-Cousin
Stollery Children’s Hospital - Dr. Bev Wilson
Children's Hospital of Eastern Ontario (CHEO) - Dr. Donna Johnston
Hamilton Health Sciences Centre, Mc Master University
BC Children’s Hospital – Dr. Juliette Hukin
Montreal Children's Hospital – Dr. Freeman
CHU Ste-Justine – Dr. Yvan Samson
CHU de Quebec – Dr. Samuele Renzi
Children's Hospital of Western Ontario – Dr. Shayna Zelcer
Janeway Hospital - Dr. Lynette Bowes
The Hospital for Sick Children - Dr. Ute Bartels
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault
Medical contact
Dr. Donna Johnston
 
Dr. Lesleigh Abbott
 
Dr. Nirav Thacker
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Isabelle Laforest
 
Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
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
 
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

Medical contact
Dr. Alexandra Zorzi
Dr. Shayna Zelcer
 
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
 
Clinical research contact
Mariam Mikhail
Medical contact
Dr. Paul Moorehead
 
Social worker/patient navigator contact
Stephanie Eason
 
Clinical research contact
Bev Mitchell
 
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

Diffuse Intrinsic Pontine Glioma (DIPG) is an aggressive brain tumour with no effective treatment and no chance of long-term survival . When this brain tumour grows back after the initial radiation therapy, it is known as progressive or recurrent DIPG.

This study will investigate how long a second treatment with radiation (re-irradiation) keeps progressive or recurrent DIPG from growing again and the overall survival of these patients. All children enrolled will be treated with re-irradiation.

Inclusion Criteria
  • The patient is 17 years of age or younger at the time of first or second relapse or progression of disease
  • The patient has no evidence of metastases on MRI of the brain and the spine
  • The patient has received radiation in the past, given to a total dose of <60 Gy
  • At least 180 days (6 months) have elapsed from the last day of primary radiation
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

LOXO-RET-18036 (LOXO 292) - A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors

Closed to enrollment

LOXO-RET-18036 (LOXO 292) - A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors

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DiagnosisSolid or brain tumour with a change in the RET geneStudy StatusClosed to enrollment
PhaseI/II
AgeChild, Adult - (6 Months to 21 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationSelpercatinib is taken by mouth (capsules or oral suspension) Participants <18 years of age may be offered to try a tablet formulation of selpercatinib.
Last Posted Update2024-09-10
ClinicalTrials.gov #NCT03899792
International Sponsor
Loxo Oncology, Inc.
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 clinical trial studies the side effects and how well selpercatinib (a medication taken by mouth) works in treating patients with solid tumors and brain tumours with a change in a gene called RET. 

Selpercatinib may stop the growth of cancer cells with RET gene changes by blocking the RET enzymes needed for cell growth.

Inclusion Criteria
  • Age between 6 months and 21 years
  • Solid tumors and brain tumours with a change in a gene called RET
  • Cancer that has come back (relapse) or is not improving despite treatment (progression)
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team