Canadian clinical trial registry

Search results

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.

89 results found

Title
Status

 

BT016C - HIFU - A Safety and Feasibility Study to Evaluate Blood Brain Barrier Disruption Using Exablate MR Guided Focused Ultrasound in Combination With Doxorubicin in Treating Pediatric Patients With Diffuse Intrinsic Pontine Gliomas (DIPG)

Open

BT016C - HIFU - A Safety and Feasibility Study to Evaluate Blood Brain Barrier Disruption Using Exablate MR Guided Focused Ultrasound in Combination With Doxorubicin in Treating Pediatric Patients With Diffuse Intrinsic Pontine Gliomas (DIPG)

Go to Health Care Provider version

DiagnosisBrain TumorStudy StatusOpen
PhaseI/II
Age5 Years to 18 YearsRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationDevice: Exablate Model 4000 Type 2.0/2.1 Drug: Doxorubicin
Last Posted Update2023-06-26
ClinicalTrials.gov #NCT05615623
International Sponsor
InSightec
Principal Investigators for Canadian Sites
The Hospital for Sick Children (SickKids) - Dr. James Rutka
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 study is to evaluate the safety and efficacy of combining Focused Ultrasound (Exablate Model 4000 Type 2.0/2.1) with Doxorubicin therapy for the treatment of DIPG in pediatric patients.

Inclusion Criteria
  • Age between 5 and 18 years, inclusive
  • Patient diagnosed with DIPG
  • Must be between 4-12 weeks from completion of radiation therapy
  • Able to attend all study visits
  • Able and willing to give consent and/or assent or have a legal guardian who is able and willing to do so
  • If brain surgery occurred, at least 14 days passed since last brain surgery and the patient is fully recovered and neurologically stable

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

NANT2015-02 - Phase 1 Study of Lorlatinib (PF-06463922), an Oral Small Molecule Inhibitor of ALK/ROS1, for Patients With ALK-Driven Relapsed or Refractory Neuroblastoma

Closed to enrollment

NANT2015-02 - Phase 1 Study of Lorlatinib (PF-06463922), an Oral Small Molecule Inhibitor of ALK/ROS1, for Patients With ALK-Driven Relapsed or Refractory Neuroblastoma

Go to Health Care Provider version

DiagnosisNeuroblastomaStudy StatusClosed to enrollment
PhaseI
AgeChild, Adult, Older Adult - (1 Year to 90 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationLorlatinib: Oral (tablet) Cyclophosphamide: IV Topotecan: IV
Last Posted Update2023-06-05
ClinicalTrials.gov #NCT03107988
International Sponsor
New Approaches to Neuroblastoma Therapy Consortium
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

Some neuroblastoma have a specific genetic change or mutation called an ALK aberration.  ALK, or anaplastic lymphoma kinase, has been found in several adult and pediatric cancers.  ALK aberrations are present in about 14% of newly diagnosed patients with high-risk neuroblastoma, and can be found more frequently at the time of relapse.  Lorlatinib is a drug called an ALK inhibitor. It is expected to slow or stop the growth of cancer cells which have the ALK aberration. The aim of this phase I/II study is to evaluate the dose, safety, and tolerability of lorlatinib, including the effect it has on the cancer.  Lorlatinib will be given alone or in combination with chemotherapy in children with refractory, relapsed or progressive neuroblastoma with ALK alterations.

Inclusion Criteria
  • Patients must have a diagnosis of neuroblastoma either by histologic verification (looking at a sample of the tumour under a microscope) of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines (HVA/VMA).
  • Patients are required to have an activating ALK aberration in their tumor, which is identified through genetic testing.
  • Patients must have high risk neuroblastoma. Patients who were initially considered low or intermediate risk, but then reclassified as high risk are also eligible.
  • Patients must have at least ONE of the following: 1) Recurrent/progressive disease at any time prior to study enrollment, 2) Refractory disease, 3) Persistent disease

 

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

PEPN2112 - A Phase 1/ 2 Study of BAY 1895344 (Elimusertib, NSC#810486) in Pediatric Patients With Relapsed or Refractory Solid Tumors

Closed to enrollment

PEPN2112 - A Phase 1/ 2 Study of BAY 1895344 (Elimusertib, NSC#810486) in Pediatric Patients With Relapsed or Refractory Solid Tumors

Go to Health Care Provider version

DiagnosisRecurrent/Refractory Alveolar Rhabdomyosarcoma, Ewing Sarcoma, Lymphoma, Malignant Solid Neoplasm Study StatusClosed to enrollment
PhaseI/II
Age12 Months to 30 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Elimusertib (BAY1895344, ATR inhibitor, ATR kinase inhibitor) Given PO (oral)
Last Posted Update2023-05-26
ClinicalTrials.gov #NCT05071209
International Sponsor
National Cancer Institute (NCI)
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 phase I/II trial tests the safety, best dose, and whether elimusertib works in treating patients with solid tumors that have come back (relapsed) or does not respond to treatment (refractory). Elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Inclusion Criteria
  • Age Restrictions: 
    • Part A:
      • Patients between >= 12 months and < 18 years of age
    • Part B:
      • Patients between >= 12 months and =< 30 years of age for the phase 2 expansion cohorts for both EWS and PAX3-FOXO1 ARMS.
      • Patients between >= 12 months and =< 21 years of age for the phase 2 DDR expansion cohort
  • Patients must be able to swallow tablets of the study drug (elimusertib)
  • Patients must have a solid tumor diagnosis that has come back (relapsed) or has not respond to treatment (refractory)
    • NOTE: further restrictions may apply for each cohort and will be discussed with you by the clinical team
  • Patients must have measurable disease
  • Patients must be up and about at least half of their waking hours
  • Bloodwork requirements must be met prior to treatment
  • Patients must meet the minimum duration from any prior anti-cancer therapy before enrolling. These timelines will be discussed with you by the clinical team.  
  • Patients or their substitute decision maker must sign a consent form and agree to the required study assessments

Additional inclusion and exclusion crieria may apply 

KEYNOTE-051 (MK-3475) - A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

Closed to enrollment

KEYNOTE-051 (MK-3475) - A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

Go to Health Care Provider version

DiagnosisMelanoma, Lymphoma, Solid Tumor, Hodgkin Lymphoma, Microsatellite-instability-high Solid Tumor, Non-Hodgkin Lymphoma, Other solid tumoursStudy StatusClosed to enrollment
PhaseI/II
AgeChild - (6 Months to 17 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment Administrationintravenous
Last Posted Update2023-01-05
ClinicalTrials.gov #NCT02332668
International Sponsor
Merck Sharp & Dohme Corp.
Principal Investigators for Canadian Sites
Montreal Children’s Hospital - Dr. Catherine Vézina
The Hospital for Sick Children - Dr. Vijay Ramaswamy
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
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 pembrolizumab (antibody against a marker called PD1) in children and adolescents who have any of the following types of cancer:

  • advanced melanoma (now only open for patients age 12-18)
  • advanced, relapsed or refractory cancer (except brain tumours and leukemia) that have this PD1 marker (now closed) 
  • relapsed or refractory classical Hodgkin lymphoma 
  • advanced relapsed or refractory cancer (except brain tumours and leukemia) that is known to be "microsatellite-instability-high (MSI-H)"
  • advanced relapsed or refractory cancer (except brain tumours and leukemia) that is known to be "tumor-mutational burden-high" (TMB-H)"

Pembrolizumab 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, pembrolizumab 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.

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

Inclusion Criteria
  • Age between 6 months and <18 years  (or between 3 years and <18 years of age for participants with Hodgkin's lymphoma) 
  • Locally-advanced, or metastatic cancer (except brain tumours and leukemia) that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate. The cancer type has to meet one of the following types described in the "study description" section.
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
Publications

Geoerger B, Kang HJ, Yalon-Oren M, Marshall LV, Vezina C, Pappo A, Laetsch TW, Petrilli AS, Ebinger M, Toporski J, Glade-Bender J, Nicholls W, Fox E, DuBois SG, Macy ME, Cohn SL, Pathiraja K, Diede SJ, Ebbinghaus S, Pinto N. Pembrolizumab in paediatric patients with advanced melanoma or a PD-L1-positive, advanced, relapsed, or refractory solid tumour or lymphoma (KEYNOTE-051): interim analysis of an open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2020 Jan;21(1):121-133. doi: 10.1016/S1470-2045(19)30671-0. Epub 2019 Dec 4.

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

Open

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

Go to Health Care Provider version

DiagnosisRecurrent or Progressive Diffuse Intrinsic Pontine GliomaStudy StatusOpen
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 Update2023-01-05
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. Doaa Abdel Fattah
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Carol Duchenne
 
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

CA209-744 - Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical)

Closed to enrollment

CA209-744 - Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical)

Go to Health Care Provider version

DiagnosisHodgkin Disease, Hodgkin lymphoma, relapsed, refractoryStudy StatusClosed to enrollment
PhaseII
AgeChild, Adult - (5 Years to 30 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIV
Last Posted Update2023-01-05
ClinicalTrials.gov #NCT02927769
International Sponsor
Bristol-Myers Squibb
Principal Investigators for Canadian Sites
Montreal Children's Hospital – Dr. Sharon Abish
Alberta Children's Hospital – Dr. Victor Lewis
The Hospital for Sick Children - Dr. Ute Bartels
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
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

 

 

 

Study Description

The purpose of this study is to determine whether the combination of two drugs called nivolumab and brentuximab vedotin is safe and effective in treating patients with Hodgkin's lymphoma that has come back or not responded to current therapy. 

Brentuximab vedotin is an antibody that specifically targets the CD30 marker of the Hodgkin Lymphoma cells and is able to kill them.

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's immune system to help it identify and destroy the cancer cells. It is expected to slow or stop the growth of cancer cells.

Inclusion Criteria

Child aged 5 to 18 with Hodgkin lymphoma who has already received treatment and either had no response (refractory) or experienced relapse.

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

 

20110261 - A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Non Central Nervous System Tumors That Are Amenable to Direct Injection

Closed to enrollment

20110261 - A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Non Central Nervous System Tumors That Are Amenable to Direct Injection

Go to Health Care Provider version

DiagnosisAdvanced Non-CNS Tumors, Other solid tumours Study StatusClosed to enrollment
PhaseI
AgeChild, Adult - (2 Years to 21 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationIntralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance
Last Posted Update2022-10-04
ClinicalTrials.gov #NCT02756845
International Sponsor
Amgen
Principal Investigators for Canadian Sites
CHU Ste Justine - Dr. Pierre Teira
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

Our immune system has the ability to recognize and destroy cancer cells. Under certain circumstances (eg. mutation) these cancer cells are no longer destroyed. Immunotherapy is a treatment which aims to "mobilize" the patient's immune defenses against his disease, by restoring the ability of the immune system to act against cancer cells.Talimogen laherparepvec is a product that stimulates the production of cells specialized in destroying cancer cells after being injected directly into the tumor.

The objective of this study is to evaluate the positive and negative effects induced by the injection of this new treatment. To do this, initially, children with any type of solid tumors will receive injections of dose recalculated from the dose already known for treatment of adults.Then depending on the results, the doses are gradually reduced. The effectiveness of this treatment and the analysis of its side effects will be evaluated by observing the disease's evolution, the side effects and the duration of its effects.

Inclusion Criteria
  • Children 2 to 20 years old with a recurrent solid tumor
  • Subject must be a candidate for intralesional injection, defined as one or more of the following:
    • at least 1 injectable lesion ≥ 10 mm in longest diameter
    • multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm

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

TRAM-01 - A Phase 2 Study of Trametinib for Patients With Pediatric Glioma or Plexiform Neurofibroma With Refractory Tumor and Activation of the MAPK/ERK Pathway.

Closed to enrollment

TRAM-01 - A Phase 2 Study of Trametinib for Patients With Pediatric Glioma or Plexiform Neurofibroma With Refractory Tumor and Activation of the MAPK/ERK Pathway.

Go to Health Care Provider version

DiagnosisLow grade glioma, high grade glioma, plexiform neurofibromaStudy StatusClosed to enrollment
PhaseI/II
AgeChild, Adult - (1 Month to 25 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationTrametinib (oral)
Last Posted Update2022-09-30
ClinicalTrials.gov #NCT03363217
International Sponsor
St. Justine's Hospital
Principal Investigators for Canadian Sites
Montreal Children’s Hospital – Dr. Genevieve Legault
CHU Ste-Justine – Dr. Sébastien Perreault
CHU de Quebec – Dr. Valerie Larouche
Alberta Children’s Hospital – Dr. Lucie Lafay-Cousin
BC Children’s Hospital – Dr. Juliette Hukin
The Hospital for Sick Children - Dr. Uri Tabori
Centres
Medical contact
Dr. Victor Lewis

 

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

 

 

 

Study Description

This is a study of trametinib (an oral drug called a MEK inhibitor) in children and adolescents who have any of the following types of cancer or tumours:

- patients with neurofibromatosis type 1 (NF1) that have low grade glioma, or
- patients with neurofibromatosis type 1 (NF1) that have plexiform neurofibroma,
- patients with low grade glioma that has a gene change called a BRAF fusion (in the tumour)
- patients with glioma of any grade (low or high) with activation of proteins called the MAPK/ERK pathway.

For all patients (except for those with plexiform neurofibroma), the disease must have recurred or grown in size after a first treatment.

Inclusion Criteria
  • Patient must be aged ≥ 1 month (corrected age) to ≤ 25 years at the time of study enrollment
  • Participants must belong to one of the groups described in the study description section
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
Publications

Perreault S, Larouche V, Tabori U, Hawkin C, Lippé S, Ellezam B, Décarie JC, Théoret Y, Métras MÉ, Sultan S, Cantin É, Routhier MÈ, Caru M, Legault G, Bouffet É, Lafay-Cousin L, Hukin J, Erker C, Jabado N. A phase 2 study of trametinib for patients with pediatric glioma or plexiform neurofibroma with refractory tumor and activation of the MAPK/ERK pathway: TRAM-01. BMC Cancer. 2019 Dec 27;19(1):1250. doi: 10.1186/s12885-019-6442-2.