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.

71 results found

Title
Status

 

HeadStart4 (IRB15-00399) - HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue

Open

HeadStart4 (IRB15-00399) - HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue

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DiagnosisMedulloblastoma, Central Nervous System Embryonal Tumors, Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastomaStudy StatusOpen
PhaseIV
AgeChild - (up to 10 years)RandomisationYES
Line of treatmentFirst line treatment
Routes of Treatment AdministrationIV chemotherapies
Last Posted Update2021-12-23
ClinicalTrials.gov #NCT02875314
International Sponsor
Nationwide Children's Hospital
Principal Investigators for Canadian Sites
BC Children's Hospital – Dr. Sylvia Cheng
Alberta Children's Hospital – Dr. Lucie Lafay-Cousin
The Hospital for Sick Children – Dr. Annie A. Huang
Stollery Children's Hospital – Dr. Bev Wilson
Hamilton Health Sciences Centre, McMaster University – Dr. Adam Fleming

Centres
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

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

NAIT Program 

nait.info@sickkids.ca

 

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. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 

 

 

Study Description

This study looks to assess if additional intensive treatment for patients with medulloblastoma and other embryonal brain tumors improves outcomes without adding significant short or long-term side effects. 

Inclusion Criteria

Patients 10 years of age of less with a diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord. Any stage of medulloblastoma or CNS embryonal tumor in children less than 6 years old are eligible, whereas only high risk patients from 6-10 years of age are eligible. 

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

Open

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 StatusOpen
PhaseI/II
AgeChild, Adult - (6 Months to 21 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationSelpercatinib is taken by mouth
Last Posted Update2021-12-23
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

NAIT Program 

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

BCC015 - Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Open

BCC015 - Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

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DiagnosisNeuroblastomaStudy StatusOpen
PhaseII
AgeChild, Adult - (up to 31 years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationEtoposide: oral DFMO: oral
Last Posted Update2021-12-23
ClinicalTrials.gov #NCT04301843
International Sponsor
Giselle Sholler
Principal Investigators for Canadian Sites
Montreal Children's Hospital – Dr. Sharon Abish
CancerCare Manitoba – Dr. Ashley Chopek
CHU Ste-Justine – Dr. Pierre Teira
Alberta Children's Hospital – Dr. Lucie Lafay-Cousin
CHU de Quebec - Dr. Bruno Michon
Janeway Hospital – Dr. Paul Moorehead
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

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. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

Medical contact
Dr. Paul Moorehead
 
Social worker/patient navigator contact
Stephanie Eason
 
Clinical research contact
Bev Mitchell
 

 

 

Study Description

This study is to assess the effectiveness of a drug called Difluoromethylornithine (DFMO) in combination with etoposide for patients with neuroblastoma that has come back, or is not responidng to current treatment. 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 31 years of age 
  • Diagnosis of neuroblastoma that has come back or is not responding to treatment 
  • Patients can have active or no active disease at the time of study start
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

 

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

Open

MYTHIC - 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 StatusOpen
PhaseI
Age12 years and olderRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationRP-6306 (PKMYT1 Inhibitor): Oral
Last Posted Update2021-11-30
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

NAIT Program 

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.

116540 - An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor Trametinib in Children and Adolescents Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Children and Adolescents With Cancers Harboring V600 Mutations

Completed

116540 - An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor Trametinib in Children and Adolescents Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Children and Adolescents With Cancers Harboring V600 Mutations

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DiagnosisPlexiform Neurofibroma, Neurofibromatosis, LGG, Low Grade Glioma, LCH, Langerhans Cell Histiocytosis, other solid tumors and brain tumorsStudy StatusCompleted
PhaseI/II
AgeChild - (1 Month to 17 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationTrametinib: oral (capsules, tablets or suspension) Dabrafenib: oral (capsules, tablets or suspension)
Last Posted Update2021-11-03
ClinicalTrials.gov #NCT02124772
International Sponsor
Novartis Pharmaceuticals
Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. James 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

NAIT Program 

nait.info@sickkids.ca

 

 

 

Study Description

Some diseases such as cancer with BRAF mutations, low grade gliomas and plexiform neurofibroma in patients with neurofibromatosis type 1 [NF-1], or Langerhans cell histocytosis [LCH]) have been shown to have molecular dysfunction called MAPK pathway dysregulation which favors tumour development. The MAPK pathway is involved in cell growth, differentiation, inflammation and apoptosis.Trametinib is an inhibitor of components of the MAPK pathway called MEK1 and MEK2. Drabafenib is a small molecule that inhibits the MAPK pathway in BRAF mutated cells by blocking the BRAF serine-threonine kinase. Both are expected to slow or stop the growth of cancer cells.

The aim of this phase I/II study is to evaluate the dose, safety, tolerability, antitumor activity and other pharmacologic characteristics of Trametinib alone or with Dabrafenib in children with refractory or relapsed solid cancer or disease with BRAF mutations for which no standard therapy is available or for which the subject is not eligible for the existing therapy.

The study is currently open for LCH and neuroblastoma only.

Inclusion Criteria
  • Male or female between one month and <18 years of age (inclusive) at the time of signing consent
  • Must have a disease that is relapsed/refractory to all potentially curative standard treatment regimens or must have a current disease for which there is no known curative therapy, or therapy proven to prolong survival with an acceptable quality of life.
  • The subject's disease (i.e. cancer, neurofibromatosis type 1 [NF-1] with plexiform neurofibroma [PN], or Langerhans cell histocytosis [LCH]) must have relapsed after or failed to respond to frontline curative therapy or there must not be other potentially curative treatment options available. Curative therapy may include surgery, radiation therapy, chemotherapy, or any combination of these modalities
  • Able to swallow and retain enterally administered medication

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

Open

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 StatusOpen
PhaseII
AgeChild, Adult - (up to 30 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationOral
Last Posted Update2021-10-20
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

OZM-075 - Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers

Closed to enrollment

OZM-075 - Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers

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DiagnosisRefractory or Recurrent Hypermutated Malignancies, Biallelic Mismatch Repair Deficiency (bMMRD) Positive Patients, Other solid tumours, CMMRDStudy StatusClosed to enrollment
PhaseI/II
AgeChild, Adult - (12 Months to 18 Years)RandomisationN/A
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIV
Last Posted Update2021-10-19
ClinicalTrials.gov #NCT02992964
International Sponsor
The Hospital for Sick Children
Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Daniel Morgenstern
BC Children's Hospital - Dr. Rebecca Deyell
Centres
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

NAIT Program 

nait.info@sickkids.ca

 

 

 

Study Description

Some cancer, called hypermutant cancer, have been shown to have multiple genetic changes  or abnormalities that block DNA repair and favor tumour development. Nivolumab is a human monoclonal antibody that binds and blocks PD-1 on tumors cells.  The PD-1 pathway is an immune system checkpoint that may be used by cancer tumour cells to help them trick the immune system (escape surveillance) and avoid being destroyed. By blocking the PD-1 pathway, nivolumab reactivates cells from the patient immune system to help it identify and destroy the cancer cells. It is expected to slow or stop the growth of cancer cells.

In this phase I/II study, patients will not be randomized and all enrolled on the clinical trial will receive nivolumab.  The study will evaluate the dose, safety, tolerability, effect on the cancer and other important characteristics of nivolumab.  This study includes pediatric patients with recurrent or refractory hypermutant cancer aged 12 months to 18 years, including those with  bMMRD syndrome. for which no standard therapy is available or for which the subject is not eligible for the existing therapy.

Inclusion Criteria

•    Patients must be greater than 2 months and less than 25 years of age at time of enrollment. Please note, some hospitals may not be able to treat patients above certain ages (e.g., 18 years old).
•    Recurrent or relapse paediatric cancer suspected to be hypermutant, including those exhibiting evidence of genetic or molecular alterations such as: high microsatellite instability (MSI-H) in current or previous tumour, mutation causing loss of mismatch repair gene (MLH1, MSH2, MSH6, PMS2, EPCAM or MSH3) expression, hypermutation by local sequencing in current or previous tumour, a history of CMMRD, Lynch syndrome, xeroderma pigmentosum (XP), or other established disorder affiliated with an elevated hypermutation rate, a functional mutation of polymerase genes (POLE or POLD1) in current or previous tumour, a functionally impaired RRD pathway by other means; etc. 
•    Patients must have histologic or cytologic confirmation of malignancy at the time of initial diagnosis or relapse (as specified above). Patients with multiple concurrent and/or sequential neoplasms are eligible, including CNS and haematological malignancies.
•    Patients must be able to provide tumour sample (archival or a new biopsy). If a tumour sample (including archival) is not available, a new tumour sample may be needed. Any such biopsy will not be considered a trial-related procedure.

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

EZH-102 - A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

Closed to enrollment

EZH-102 - A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

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DiagnosisRhabdoid Tumor, INI1-negative Tumors, Synovial Sarcoma, Malignant Rhabdoid Tumor, Epithelioid sarcoma, Epithelioid malignant peripheral nerve sheah tumor, Extraskeletal myxoid chondrosarcoma, myoepithelial carcinoma, Renal medullary carcinoma, Study StatusClosed to enrollment
PhaseI
AgeChild - (6 Months to 17 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment Administrationoral (suspension and tablets)
Last Posted Update2021-10-19
ClinicalTrials.gov #NCT02601937
International Sponsor
Epizyme, 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

NAIT Program 

nait.info@sickkids.ca

 

 

 

Study Description

Some rare cancer such as rhabdoid tumors or epithelioid sarcoma have been shown to have a molecular dysfunction allowing a protein called EZH2 to favour tumour developpment. Tazemetostat is an EZH2 inhibitor and is expected to slow or stop the growth of cancer cells. The aim of this Phase I study is to evaluate the dose, safety, tolerability, antitumor activity and other pharmacologic characteristics of Tazemetostat in children with refractory or relapsed solid cancer  for which no standard therapy is available or for which the subject is not eligible for the existing therapy. 

Inclusion Criteria
  • Age ≥6 months to <18 years
  • Patient has one of the specific disease targeted in this study, histologically confirmed by a CLIA/CAP certified laboratory
  • Relapsed or refractory disease and no standard treatment options as determined by locally or regionally available standards of care and treating physician's discretion
  • Patient is able to swallow and retain orally administered medication

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