Registre canadien des essais cliniques

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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.

111 results found

Title
Status

 

SJMB12 - A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

Closed to enrollment

SJMB12 - A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

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DiagnosisMedulloblastomaStudy StatusClosed to enrollment
PhaseII
AgeChild, Adult - (3 years to 39 years)RandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationVismodegib - Oral. Other drugs are given as usually administered for medulloblastoma therapy
Last Posted Update2024-03-15
ClinicalTrials.gov #NCT01878617
International Sponsor
St. Jude Children's Research Hospital
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Lucie Lafay-Cousin
The Hospital for Sick Children - Dr. Ute Bartels
CHU Ste-Justine- Dr. Sébastien Perreault
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
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
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 study will assess the molecular subtype (abbreviated WNT, SHH, Non-WNT, Non-SHH) of patients with medulloblastoma. Based on the subtype And other factors, patients will be assigned to a "risk group", each risk group receiving specific treatment with chemotherapy and radiation therapy.

Patients with a specific molecular subtype called Sonic Hedgehog (SHH) will be treated with a medication taken by mouth, called vismodegib in addition to standard therapy, to directly target the molecular pathway. 

Inclusion Criteria
  • Patients between 3 and 22 years of age with medulloblastoma.
  • Patients between 22 and 40 years with medulloblastoma of the SHH subtype are eligible.
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

GO40871 - A Phase I/II, Multicenter, Open-Label, Multi-Arm Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Patients With Relapsed/Refractory Acute Leukemias or Solid Tumors

Open

GO40871 - A Phase I/II, Multicenter, Open-Label, Multi-Arm Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Patients With Relapsed/Refractory Acute Leukemias or Solid Tumors

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DiagnosisAcute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Neuroblastoma, Solid TumorsStudy StatusOpen
PhaseI/II
AgeChild, Adult - (up to 30 Years)RandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIdasanutlin: oral Note: Other drugs are given as usually administered for acute leukemia & solid tumor therapy
Last Posted Update2024-03-15
ClinicalTrials.gov #NCT04029688
International Sponsor
Hoffmann-La Roche
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Melanie Finkbeiner
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich

 

 

Study Description

This study seeks to test the safety and effectiveness of the drug taken by mouth called idasanutlin when taken together with chemotherapy or other cancer drugs (venetoclax) to treat acute leukemias or solid tumors in pediatric or young adults. 

The study is divided into 3 parts. The first part of the study aims to figure out the maximum dose of idasanutlin that can be safely tolerated as well as the recommended dose of idasanutlin when used in combination with chemotherapy and other cancer drugs (venetoclax).

The second part of the study aims to test the safety and effectiveness of idasanutlin in combination with chemotherapy and other cancer drugs (venetoclax) for treating neuroblastoma, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL).

The third part of the study further monitors patients for additional responses to idasanutlin and safety assessments.

Inclusion Criteria
  • Age less than 18 years old or less than 30 years old depending on study groups
  • Diagnosis of neuroblastoma, acute myeloid leukemia (AML), or acute lymphoblastic leukemia (ALL) that has worsened or come back despite the use of standard therapy.
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

PED-CITN-03 - Phase 1 Trial of Hu5F9-G4 (Magrolimab) Combined With Dinutuximab in Children and Young Adults With Relapsed and Refractory Neuroblastoma or Relapsed Osteosarcoma

Closed to enrollment

PED-CITN-03 - Phase 1 Trial of Hu5F9-G4 (Magrolimab) Combined With Dinutuximab in Children and Young Adults With Relapsed and Refractory Neuroblastoma or Relapsed Osteosarcoma

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DiagnosisNeuroblastoma, OsteosarcomaStudy StatusClosed to enrollment
PhaseI
AgeChild, Adult - (up to 35 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDinutuximab: intravenous Magrolimab: intravenous
Last Posted Update2024-02-13
ClinicalTrials.gov #NCT04751383
International Sponsor
COG Pediatric Early Phase Clinical Trials Network (PEP-CTN)
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel A. Morgenstern
BC Children's Hospital - Dr. Rebecca Deyell
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
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

 

 

Study Description

The purpose of this study is to determine the best dose, benefits and/or side effects of 2 drugs (magrolimab and dinutuximab) when given in combination to treat neuroblastoma that has come back (relapsed) or does not respond to treatment (refractory), or osteosarcoma that has come back (relapsed). These drugs (magrolimab and dinutuximab) interfere with the ability of cancer cells to grow and spread, using them in treatment may stop or shrink cancer growth in cases of neuroblastoma and osteosarcoma.

An additional aim of this study is determining the safety of these drugs (magrolimab and dinutuximab) when given after surgery to remove tumors from the lungs.

Inclusion Criteria
  • Age between 1 and 35 years
  • Patients must have:
    • neuroblastoma that has come back (relapsed) or does not respond to treatment (refractory) or
    • osteosarcoma that has come back (relapsed)
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

ADVL1823 - Larotrectinib (LOXO-101, NSC# 788607) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias

Closed to enrollment

ADVL1823 - Larotrectinib (LOXO-101, NSC# 788607) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias

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Diagnosis Infantile fibrosarcoma with TRK fusion, any solid tumour with TRK fusion, any brain tumour with TRK fusion (except high grade glioma), any relapsed acute leukemia with TRK fusionStudy StatusClosed to enrollment
PhaseII
AgeChild, Adult - (up to 30 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationOral
Last Posted Update2024-02-12
ClinicalTrials.gov #NCT03834961
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
IWK Health Centre - Dr. Craig Erker
CHU Sainte-Justine - Dr. Yvan Samson
Montreal Children's Hospital – Dr. Sharon Abish
Centres
Medical contact
Dr. Craig Erker
Dr. Conrad Fernandez 
Dr. Ketan Kulkarni 
 
Social worker/patient navigator contact
Rhonda Brophy
 
Clinical research contact
Tina Bocking
 
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
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 

 

 

Study Description

This clinical trial studies the side effects and how well larotrectinib (a medication taken by mouth) works in treating patients with

  • solid tumors and brain tumours with a specific gene change called a "TRK fusion", previously untreated
  • acute leukemia that has come back, and has a specific gene change called a "TRK fusion".

Larotrectinib may stop the growth of cancer cells with TRK fusions by blocking the TRK enzymes needed for cell growth.

Inclusion Criteria
  • Age up to 30 years
  • Patients must fit into one of the 3 groups
    • Group A: diagnosis of infantile fibrosarcoma with a specific gene change called a "TRK fusion". The patient will have received no prior anti-cancer therapy, including radiotherapy, other than surgical resection (operation to remove the tumour)
    • Group B: diagnosis of any solid tumor including brain tumours (except high grade gliomas), with a specific gene change called a "TRK fusion". The patient will have received no prior anti-cancer therapy, including radiotherapy, other than surgical resection (operation to remove the tumour)
    • Group C: diagnosis of acute leukemia that has come back, and has a specific gene change called a "TRK fusion".
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

MYTHIC (RP-6306) - Phase 1 Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 in Patients With Advanced Solid Tumors (MYTHIC Study)

Closed

MYTHIC (RP-6306) - Phase 1 Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 in Patients With Advanced Solid Tumors (MYTHIC Study)

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DiagnosisAdvanced Solid TumorStudy StatusClosed
PhaseI
Age12 years and olderRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationRP-6306 (PKMYT1 Inhibitor): Oral
Last Posted Update2024-01-19
ClinicalTrials.gov #NCT04855656
International Sponsor
Repare Therapeutics
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

(via: https://www.mskcc.org/cancer-care/clinical-trials/21-303)

The purpose of this study is to find the highest dose of the investigational drug RP-6306 that can be used in advanced solid tumors containing certain genetic changes and which have come back or continued to grow despite prior treatment. 

RP-6306 blocks the protein PKMY1, which plays a major role in the survival and growth of cancers with the genetic changes being studied in this clinical trial. RP-6306 is taken orally (by mouth).

Inclusion Criteria

(via: https://www.mskcc.org/cancer-care/clinical-trials/21-303)

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a locally advanced or metastatic solid tumor that has come back or continued to grow despite prior treatment
  • Participants’ tumors must contain a mutation in the FBXW7 or PPP2R1A genes or extra copies of the CCNE1 gene
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours
  • This study is for people age 12 and older

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

YmAbs201 - A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Open

YmAbs201 - A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Go to Health Care Provider version

DiagnosisNeuroblastomaStudy StatusOpen
PhaseII
AgeChild, Adult, Older Adult - (1 Year and older)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment Administrationnaxitamab (intravenous); GM-CSF (sub-cutaneous)
Last Posted Update2024-01-19
ClinicalTrials.gov #NCT03363373
International Sponsor
Y-mAbs Therapeutics
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 study of naxitamab, also known as hu3F8, a humanised antibody targeting GD2 in children and adults diagnosed with high-risk neuroblastoma. GD2 is a marker present at the surface of the neuroblastoma cells; therefore the naxitamab can target the neuroblastoma cells and stimulate the immune system to kill them.

Patients with with primary refractory disease (disease that has never improved with previous treatment), or patients that have had a relapse but incomplete response of the disease in bone and/or bone marrow from salvage treatment will be considered for this study.

Granulocyte-macrophage colony stimulating factor (GM-CSF) will be given along naxitamab.

Inclusion Criteria
  • Diagnosis of high-risk neuroblastoma with disease in bone and/or bone marrow.
  • High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

ACT15378 ISAKIDS - Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

Suspended

ACT15378 ISAKIDS - Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

Go to Health Care Provider version

DiagnosisAcute Lymphoblastic Leukemia, Acute Myeloid LeukemiaStudy StatusSuspended
PhaseII
AgeChild - (up to 17 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIntravenous for isatuximab; Other drugs as usually administered for leukemia therapy
Last Posted Update2024-01-08
ClinicalTrials.gov #NCT03860844
International Sponsor
Sanofi
Principal Investigators for Canadian Sites
Montreal Children’s Hospital - Dr. Surabhi Rawal
BC Children's Hospital - Dr. Amanda Li
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

 

 

Study Description

This is study of a new medication called isatuximab (antibody against a marker called CD38) in combination with standard chemotherapy for children with acute lymphoblastic leukemia or acute myeloid leukemia that has relapsed or is refractory to treatment. The main objective of this study is to understand the anti-leukemia effect of this medication. 

Inclusion Criteria
  • Age between 28 days to less than 18 years of age
  • Acute lymphoblastic leukemia or acute myeloid leukemia that has relapsed or is refractory to treatment
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

OZM-063 - A Phase II, Open-Labeled, Multi-Center, Randomized Controlled Trial of Vinblastine +/- Bevacizumab for the Treatment of Chemotherapy-Naïve Children With Unresectable or Progressive Low Grade Glioma (LGG)

Closed to enrollment

OZM-063 - A Phase II, Open-Labeled, Multi-Center, Randomized Controlled Trial of Vinblastine +/- Bevacizumab for the Treatment of Chemotherapy-Naïve Children With Unresectable or Progressive Low Grade Glioma (LGG)

Go to Health Care Provider version

DiagnosisLow Grade GliomaStudy StatusClosed to enrollment
PhaseII
AgeChild, Adult - (6 Months to 18 Years)RandomisationYES
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment Administrationintravenous
Last Posted Update2024-01-08
ClinicalTrials.gov #NCT02840409
International Sponsor
The Hospital for Sick Children / Hoffmann-La Roche
Principal Investigators for Canadian Sites
Montreal Children’s Hospital – Dr. Geneviève Legault
The Hospital for Sick Children – Dr. Uri Tabori
Alberta Children’s – Dr. Lucie Lafay-Cousin
BC Children’s Hospital – Dr. Juliette Hukin
CHU Ste-Justine – Dr. Yvan Samson
Stollery Children’s Hospital – Dr. Bev Wilson
CHU de Quebec - Dr. Valerie Larouche
CancerCare Manitoba - Dr. Issai Vanan
Children’s Hospital of Eastern Ontario (CHEO) - Dr. Donna L. Johnston
Hamilton Health Sciences Centre - Dr. Uma Athale
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
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

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

 

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
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
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
 
 

 

 

Study Description

This study is trying to determine the benefit of adding bevacizumab (an intravenous drug) to chemotherapy treatment with vinblastine, in children and adolescents with low grade gliomas.

Participants in this trial will be randomised (randomly assigned) into one of two treatment arms.

  • Arm A will include 68 weeks (16 months) of single agent Vinblastine given once weekly intravenously.
  • Arm B will include 68 weeks (16 months) of Vinblastine given weekly intravenously with the addition of 12 doses of bevacizumab given every two weeks intravenously for the initial 24 weeks (6 months).
Inclusion Criteria
  • Children and adolescents aged 6 months to < 18 years
  • Low grade glioma 
  • The tumour must have grown back after surgery with clear imaging or clinical signs, or
  • The tumour was partially removed with surgery and there is a necessity to begin treatment because of a risk of neurological impairment with progression.
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team