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.

86 results found

Title
Status

 

CDRB436G2201 - Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)

Closed to enrollment

CDRB436G2201 - Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)

Go to Health Care Provider version

DiagnosisLow Grade Glioma, relapsed or refractory high grade glioma with BRAF V600 mutationStudy StatusClosed to enrollment
PhaseII
AgeChild - (12 Months to 17 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDabrafenib and trametinib (oral). Other drugs are given as usually administered for low grade glioma therapy.
Last Posted Update2022-04-25
ClinicalTrials.gov #NCT02684058
International Sponsor
Novartis Pharmaceuticals
Principal Investigators for Canadian Sites
BC Children’s Hospital – Dr. Juliette Hukin
The Hospital for Sick Children - Dr. Uri Tabori
Montreal Children's Hospital – Dr. Catherine Vézina
CHU Ste-Justine – Dr. Sébastien Perreault


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

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
 
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

(Translated from summary in French available on u-link.eu for the same study)

Gliomas are the most common brain tumors in children. They are classified into two groups: low-grade gliomas common in younger people and high-grade malignant gliomas that affect older children or adolescents. Genetic studies of these tumors have made it possible to highlight specific mutations which open the opportunity to new therapeutic avenues when standard treatments have not been effective.

In this protocol a combination of two drugs is used:

  • Dabrafenib blocks a cellular process necessary for cell proliferation (it is a BRAF inhibitor)
  • Trametinib blocks another process necessary for cell proliferation (it is a MEK inhibitor)

This study explores the efficacy and tolerance of these two new medications taken together.

Their association is studied on the two groups of glioma as follows:

  • For children with high-grade glioma who have not responded to the standard treatment, the two molecules are taken orally every day.
  • For children with low-grade glioma, the children are divided into 2 groups by drawing lots (randomization):
    • The first group receives the two molecules orally every day.
    • The second group receives classical chemotherapy (vincristine and carboplatin) according to standard of care. If the disease progresses despite these treatments, patient will be able to receive the two molecules tested
  • In all cases the tumour will need to have a marker called BRAF V600 for the child to be considered for this study

 

Inclusion Criteria

(Translated from summary in French available on u-link.eu for the same study)

  • Child aged 1 to 18
  • Low or high grade glioma to whom standard treatments have not produced a sufficient response or who have relapsed.
  • In all cases the tumour will need to have a marker called BRAF V600 for the child to be considered for this study
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

AALL15P1 - A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement

Closed to enrollment

AALL15P1 - A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement

Go to Health Care Provider version

DiagnosisALL, Acute Lymphoblastic Leukemia Study StatusClosed to enrollment
PhaseII
AgeChild - up to 364 daysRandomisationN/A
Line of treatmentFirst line treatment
Routes of Treatment AdministrationAzacitidine IV Other drugs are given as usually administered for ALL therapy
Last Posted Update2022-04-25
ClinicalTrials.gov #NCT02828358
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
CancerCare Manitoba – Dr. Ashley Chopek
Children's Hospital of Western Ontario – Dr. Shayna Miriam Zelcer
The Hospital for Sick Children – Dr. Ute Bartels
IWK Health Centre – Dr. Craig Erker
Cancer Centre of Southeastern Ontario at Kingston General Hospital – Dr. Mariana Silva
Montreal Children's Hospital - Dr. Sharon Abish
Children’s Hospital of Eastern Ontario (CHEO) – Dr. Donna Johnston
Janeway Hospital – Dr. Lisa Goodyear
Centres
Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

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. Laura Wheaton
Dr. Mariana Silva
 
Social worker/patient navigator contact
Jessica Amey
 
Clinical research contact
Heather McLean
 
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. 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
 
Medical contact
Dr. Donna Johnston
Dr. Lesleigh Abbott
Dr. Doaa Abdel Fattah
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Carol Duchenne
 
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 chemotherapy called azacitidine in addition to the standard chemotherapy in infants diagnosed with acute lymphoblastic leukemia with a certain mutation called KMT2A-rearrangement.

Enrolled patients will receive four courses of azacitidine during their treatment. The study also looks at the side effects associated with these medications.

Inclusion Criteria
  • Children less than 1 year of age
  • New diagnosis of acute lymphoblastic leukemia
  • Presence of a change called "KMT2A-rearrangement" in the leukemia cells

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

TINI - Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

Closed to enrollment

TINI - Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

Go to Health Care Provider version

DiagnosisALL, Acute Lymphoblastic LeukaemiaStudy StatusClosed to enrollment
PhaseI/II
AgeChild - up to 365 daysRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationBortezomib: intravenous: Vorinostat: orally; Other drugs are given as usually administered for ALL therapy
Last Posted Update2022-04-19
ClinicalTrials.gov #NCT02553460
International Sponsor
St. Jude Children's Research Hospital
Principal Investigators for Canadian Sites
BC Children's Hospital - Dr. Kirk R. Schultz
Alberta Children's Hospital - Dr. Victor A. Lewis
Hamilton Health Sciences Centre, McMaster University - Dr. Uma Athale
CHU Ste-Justine - Dr. Thai Hoa Tran
CHU de Quebec - Dr. Bruno Michon
Montreal Children's Hospital - Dr. Catherine Vezina
Stollery Children's Hospital - Dr. Sunil Desai
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. 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
 
 
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

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
 

 

 

Study Description

This study is to assess the effectiveness of two drugs (bortezomib and vorinostat) in addition to standard therapy, for the treatment of infants with a new diagnosis of acute lymphoblastic leukemia. 

The study also looks at the side effects associated with these medications.

Bortezomib is a drug called a "proteasome inhibitor" while vorinostat is a drug called an "HDAC inhibitor".

 

Inclusion Criteria
  • Children younger than 365 days of age with a new diagnosis of acute lymphoblastic leukemia
  • They cannot have had prior treatment with other chemotherapies (with exception of a few medications, with limited amount of doses given).
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

NANT 2019-01 - A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma

Closed to enrollment

NANT 2019-01 - A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma

Go to Health Care Provider version

DiagnosisNeuroblastomaStudy StatusClosed to enrollment
PhaseI
AgeChild, Adult - (2 Year to 21 Years)RandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationLY3295668/Erbumine taken by mouth (capsules) Topotecan and cyclophosphamide will be given intravenously
Last Posted Update2022-03-01
ClinicalTrials.gov #NCT04106219
International Sponsor
Eli Lilly and Company
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

The reason for this study is to see if the study medication LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma (neuroblastoma that has come back or is not improving despite treatment). LY3295668 erbumine blocks a protein called Aurora kinase A. Aurora kinase A is thought to contribute to the aggressiveness of neuroblastoma cells. 

The medication will be given either alone or in combination with chemotherapy.

Inclusion Criteria
  • Age between 2 and 21 years
  • Neuroblastoma that has come back (relapse) or is not improving despite treatments (refractory)
  • The child must be able to swallow capsules
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

MS100070-0306 - Open-label, Phase I/II Study to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Anticancer Activity of Avelumab in Pediatric Subjects From Birth to Less Than 18 Years of Age With Refractory or Relapsed Solid Tumors and Lymphoma

Completed

MS100070-0306 - Open-label, Phase I/II Study to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Anticancer Activity of Avelumab in Pediatric Subjects From Birth to Less Than 18 Years of Age With Refractory or Relapsed Solid Tumors and Lymphoma

Go to Health Care Provider version

DiagnosisRefractory or relapsed solid tumors, Lymphoma, Non-Hodgkin lymphoma, Other solid tumoursStudy StatusCompleted
PhaseI/II
AgeChild, Adult - (up to 18 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIV
Last Posted Update2022-02-23
ClinicalTrials.gov #NCT03451825
International Sponsor
EMD Serono Research & Development Institute, Inc.
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
CHU Ste Justine - Dr. Yvan Samson
Children's Hospital of Western Ontario - Dr. Alexandra Zorzi
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
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. 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 is a study to evaluate the dose, safety, tolerability, antitumor activity and other pharmacologic characteristics of avelumab (an antibody that binds and blocks PDL-1 on tumour cells).

This study has two parts. Part 1 will find the recommended dose for avelumab therapy and evaluate its safety. Part 2 will further evaluate the efficacy of avelumab therapy.

Inclusion Criteria
  • Age between 0 and 18
  • Solid malignant tumors (including brain tumors) or lymphoma for which no standard therapy is available, or with confirmed progression, or refractory to standard therapy
  • Availability of tumor sample collected prior to avelumab treatment for subjects in Phase 2
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

OLIE - A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination With Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults With Relapsed or Refractory Osteosarcoma (OLIE)

Completed

OLIE - A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination With Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults With Relapsed or Refractory Osteosarcoma (OLIE)

Go to Health Care Provider version

DiagnosisOsteosarcoma Study StatusCompleted
PhaseII
AgeChild, Adult - (2 Years to 25 Years) RandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationLevatinib taken by mouth (oral capsules or liquid) Ifosfamide and Etoposide administered through intravenous infusion
Last Posted Update2022-02-22
ClinicalTrials.gov #NCT04154189
International Sponsor
Eisai 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 whether adding an oral medication called lenvatinib to chemotherapy with ifosfamide/etoposide improves outcomes for patients with osteosarcoma that has come back (relapse). 

Lenvatinib blocks cell proteins and signals directed at blood vessels that help the cancer to survive.

Patients can be treated in two different arms: Arm A: chemotherapy + lenvatinib or  Arm B : chemotherapy. The participants will be divided by chance into those two separate groups through a computerised process. The treating team will NOT decide into which arm a given patient will be assigned. At this time, it is not known which treatment option is best.

 

Inclusion Criteria
  • Age between 2 and 25 years
  • Osteosarcoma that has come back (relapse) or is not improving despite treatments (refractory)
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

E7080-A001-216 ADVL1711 - A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors

Completed

E7080-A001-216 ADVL1711 - A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors

Go to Health Care Provider version

DiagnosisHigh Grade Glioma, Ewing sarcoma, RhabdomyosarcomaStudy StatusCompleted
PhaseI/II
AgeChild, Adult - (2 Years to 21 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationOral hard tablets or suspension
Last Posted Update2022-02-14
ClinicalTrials.gov #NCT03245151
International Sponsor
Eisai Inc.
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
IWK Health Centre - Dr. Craig Erker
Montreal Children's Hospital - Dr. Sharon Abish



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
Dr. Craig Erker
Dr. Conrad Fernandez 
Dr. Ketan Kulkarni 
 
Social worker/patient navigator contact
Rhonda Brophy
 
Clinical research contact
Tina Bocking
 
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 

 

 

Study Description

This is a study of two medications taken by mouth, called lenvatinib and everolimus. Lenvatinib blocks cell proteins and signals directed at blood vessels that help the cancer to survive. Everolimus is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body. It is called an mTOR inhibitor.

The phase 1 of this study has been completed, and now the phase 2 is on-going to understand the anti-cancer activity of those two medications taken together in patients with Ewing sarcoma, rhabdomyosarcoma or high grade glioma that has come back (relapsed) or is refractory to treatment.

Inclusion Criteria
  • Age from 2 years to 21 years
  • Diagnosis of Ewing sarcoma, rhabdomyosarcoma or high grade glioma that has come back (relapsed) or is refractory to treatment
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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

Go to Health Care Provider version

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

New Agent and Innovative Therapies (NAIT) 

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.