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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.

117 results found

Title
Status

 

EPG-HU1418-201 - A Phase 2/3 Study to Characterize and Evaluate the Efficacy, Safety, and Tolerability of hu14.18K322A Treatment Given in Combination With Chemotherapy in Participants With High-Risk Neuroblastoma

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EPG-HU1418-201 - A Phase 2/3 Study to Characterize and Evaluate the Efficacy, Safety, and Tolerability of hu14.18K322A Treatment Given in Combination With Chemotherapy in Participants With High-Risk Neuroblastoma

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DiagnosisHigh-Risk NeuroblastomaStudy StatusOpen
PhaseII/III
Age18 Months to 18 YearsRandomisationYES
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: hu1418K322A + Temozolomide + Irinotecan (IV)
Last Posted Update2026-08-14
ClinicalTrials.gov #NCT07549321
International Sponsor
Renaissance Pharma Ltd.
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

Neuroblastoma is the most common type of solid cancer found outside the brain in young children. Generally, it affects children younger than 5 years old, with the average age when it is found being just 2 years. Most patients have 'high-risk' disease, with spread of the disease to different sites of the body. This study aims to find out how effective and safe the treatment of an antibody called daretabart (hu14.18K322A) is when used together with chemotherapy to treat children and young people who have high-risk neuroblastoma.

Inclusion Criteria
  • Patients must be between 18 months and 18 years of age.
  • Patients must have newly diagnosed high-risk neuroblastoma that has spread to other parts of the body.
  • Patients must have neuroblastoma that can be measured or monitored by the study team.
  • Patients must be well enough to take part in the study and perform some normal daily activities.
  • Must have recovered from the side effects of previous chemotherapy.
  • Must be at least 2 weeks past any major tumor surgery.
  • Must meet all blood and organ function requirements
  • Patients who could become pregnant/father a child must have a negative pregnancy test and use effective birth control during the study and for 6 months after treatment ends.
  • Patients must be willing to take part in all required study visits and procedures.
  • Patients and/or their parent or legal guardian must provide consent

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

OPTIMISE - ARM A - Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer

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OPTIMISE - ARM A - Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer

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DiagnosisRelapsed/Refractory Solid tumour (+ lymphoma) or CNS tumourStudy StatusOpen
PhaseI/II
Age0 Years to 21 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationArm A | Drug: Irinotecan (IV), Temozolomide (Oral), Paxalisib (Oral)
Last Posted Update2026-08-12
ClinicalTrials.gov #NCT06208657
International Sponsor
Australian & New Zealand Children's Haematology/Oncology Group
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
CHU Sainte. Justine - Dr. Monia Marzouki
BC Children's Hospital - Dr. Rebecca Deyell
CHEO - Dr. Johnston 
Stollery -
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. 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
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Dr. Donna Johnston
 
Dr. Lesleigh Abbott
 
Dr. Nirav Thacker
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Doaa Abdelfattah
 
Isabelle Laforest
 
 
Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault

 

 

Study Description

 

 This study is eligible for STEP-1 funding. Find more information here. 

 

Both Australia (Zero Childhood Cancer) and Canada (PROFYLE) have programs that study the genetics of childhood cancers to help find better treatments. OPTIMISE is a study that matches patients with new treatments based on their tumor’s genetic profile. The study tests different treatment combinations to find the most effective ones for children with cancer.

The information below is for Treatment Arm A which will be combining a drug called paxalisib with conventional chemotherapy in children and adolescents with cancer.

Inclusion Criteria
  • Patients must have a cancer that hasn't responded to regular treatment or doesn't have a good treatment option
  • They must be under 21 years old. Patients 21 years and older may be considered with approval if they have a childhood-type cancer
  • They need to be part of a precision medicine study (like PROFYLE, ZERO or equivalent)
  • Must meet tumor measurement requirements
  • Must be up and about at least 50% of patients waking hours
  • Patients need to be fully recovered from past treatments
  • Must meet all organ function and bloodwork requirements
  • Must agree to allowable methods of birth control. Participants may not be pregnant on this study. 
  • Must agree to sign a consent form and to the study activities

 

Arm A specific: 

  • Cohort A1: Patients must have disease that can seen on a scan.
  • Cohort A2: Patients must have a mutation in the appropriate genetic pathway (called PI3K/AKT/mTOR) which will be confirmed by a tumour DNA testing
  • Cohort A3: Patients can join if their tumour shows any genetic change in the pathway above, even if not from the specific mutations from Cohort A2
  • Adequate cardiac function

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

MIRV - A Phase 1/2 Study of Mirdametinib and Vinblastine for Newly Diagnosed or Previously Untreated Patients With Pediatric Low-grade Glioma and Activation of the MAPK Pathway

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MIRV - A Phase 1/2 Study of Mirdametinib and Vinblastine for Newly Diagnosed or Previously Untreated Patients With Pediatric Low-grade Glioma and Activation of the MAPK Pathway

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DiagnosisPediatric Low-grade GliomaStudy StatusOpen
PhaseI/II
Age2 Years to 25 YearsRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationDrug: Mirdametinib (oral) Drug: Vinblastine (IV)
Last Posted Update2026-08-12
ClinicalTrials.gov #NCT06666348
International Sponsor
St. Justine's Hospital
Principal Investigators for Canadian Sites
CHU Sainte-Justine - Dr. Sebastian Perreault
The Hospital for Sick Children - Dr. Anthony Liu
London Children's Hospital - Dr. Shayna Zelcer
BC Children's Hospital - Dr. Sylvia Cheng
Stollery - Dr. Liana Nobre
Montreal Children's Hospital - Dr. Geneviève Legault
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
 
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
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

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
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 

 

 

Study Description

This is a research study combining an oral drug called mirdametinib with an intravenous chemotherapy drug called vinblastine for the treatment of patients with pediatric low grade glioma with certain mutations. 

In this first part, doctors will carefully test different dose levels of the two medicines to find the safest and most appropriate dose to use in the next phase. Patients will take mirdametinib by mouth twice a day at a set dose for 13 treatment cycles (each cycle is 28 days). They will also receive vinblastine through an IV once a week for 17 cycles. If side effects happen, the dose can be lowered up to two times to keep treatment safe. After treatment ends, patients will come back for check-ups every 6 months for 3 years. These visits help doctors track how the tumour responds over time and how patients are doing overall.

Inclusion Criteria
  • A parent or substitute decision maker (or the participant if they have capacity) must sign a consent form before joining the study
  • Participants need to be able to come to scheduled appointments, take study medicines as instructed, complete lab tests, and have MRIs as part of their care
  • Participants must be between 2 and 25 years old when starting mirdametinib.
  • Participants must have a type of low-grade brain tumour (PLGG) with one of the following:
    • An NF1 gene change (based on medical criteria or genetic testing), or
    • A KIAA1549-BRAF fusion, or
    • Another MAPK pathway change, except for the BRAF V600E mutation.
  • Tumour tissue is needed for testing (usually a stored tissue block, and fresh frozen tissue if available).
    • Children with NF1 and low-grade glioma can still join even if they never had surgery or a biopsy.
  • A recent MRI before starting 
  • Must be well enough to take part in daily activities at least 50% of waking hours
  • Organ and bone marrow function and body surface area must be within allowable limits
  • Teens and adults who could become pregnant must use effective birth control during the study
  • Must be able to swallow the medication by mouth, as this drug cannot be given through feeding tubes

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

DECRYPT-BABYBRAIN - A Pilot Study of Intrathecal Topotecan and Maintenance Chemotherapy in the Post-consolidation Setting for the Treatment of High-risk Embryonal Central Nervous System Tumours in Children Less Than 6 Years of Age

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DECRYPT-BABYBRAIN - A Pilot Study of Intrathecal Topotecan and Maintenance Chemotherapy in the Post-consolidation Setting for the Treatment of High-risk Embryonal Central Nervous System Tumours in Children Less Than 6 Years of Age

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DiagnosisCentral nervous system (CNS) HR-EBT: Embryonal Tumor (various), Group 3 and 4 Medulloblastoma, Atypical Teratoid Rhabdoid Tumor, Pineoblastoma, CNS Neuroblastoma, MedulloepitheliomaStudy StatusOpen
PhaseI
Ageup to (and including) 6 Years oldRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationInduction Phase: - Drug: Double Therapy (Cytarabine, Hydrocortisone) - intrathecal (IT) - Drug: Cisplatin - intravenous (IV) - Drug: Vincristine - intravenous (IV) - Drug: Etoposide - intravenous (IV) - Drug: Cyclophosphamide - intravenous (IV) - Drug: Mesna - intravenous (IV) - Drug: Filgrastim - subcutaneous or intravenous (SC or IV) Consolidation Phase: - Drug: Carboplatin - intravenous (IV) - Drug: Thiotepa - intravenous (IV) - Drug: Filgrastim - subcutaneous or intravenous (SC or IV) Maintenance Arms (A and/or B): - Drug: Topotecan - intrathecal (IT) - Drug (Maintenance A Only): Tamoxifen - oral (PO) - Drug: ISOtretinoin - oral (PO) - Drug (Maintenance B Only): Celecoxib - oral (PO) - Drug (Maintenance B Only): Temozolomide - oral (PO) - Drug (Maintenance B Only): Cyclophosphamide - oral (PO) - Drug (Maintenance B Only): Etoposide - oral (PO)
Last Posted Update2026-08-12
ClinicalTrials.gov #NCT06942039
International Sponsor
C17 Council
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Annie Huang
CHU Ste. Justine - Dr. Sébastien Perreault
Alberta Children's Hospital - Dr. Lucie Lafay-Cousin
BC Children's Hospital - Dr. George Michaiel
London Children's Hospital - Dr. Shayna Zelcer
Stollery Children's Hospital - Dr. Liana Nobre
CHU de Quebec - Dr. Valerie Larouche
CancerCare Manitoba - Dr. Divya Subburaj
Montreal Children's Hospital - Dr Christina Coleman
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. 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. Alexandra Zorzi
Dr. Shayna Zelcer
 
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
 
Clinical research contact
Mariam Mikhail
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. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

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
 

 

 

Study Description

 

If you are a long-distance patient of >160 km, one way - you may be eligible for STEP-1 travel funding. Find more information here. 

 

A pilot study to see if it is possible and safe to add medicine given into the spinal fluid (intrathecal chemotherapy) and continued treatment (maintenance therapy) after strong chemotherapy for young children under 6 years old who have newly diagnosed high-risk brain tumors.

Inclusion Criteria
  • Age: Children 6 years old or younger at the time their brain tumor is confirmed.
  • Tumor types: Certain rare, aggressive brain or spinal tumors, including ATRT, medulloblastoma (group 3 or 4), pineoblastoma, ETMR, and other similar embryonal brain tumors.
  • MRI scans: MRI of the brain and spine (with and without contrast) must be done before and after surgery.
  • Lumbar puncture (spinal tap): A sample of spinal fluid is recommended (if safe to do) before or after surgery, but not required.
  • Must meet all lab and organ function requirements
  • Must be well enough to be up and about at least 50% of waking hours

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

EMBOLD Sarcoma-202 - Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas

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EMBOLD Sarcoma-202 - Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas

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DiagnosisSarcomaStudy StatusOpen
PhaseI/II
Age≥ 12 years of ageRandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationBiological: Ris-Rez (IV)
Last Posted Update2026-07-24
ClinicalTrials.gov #NCT07602777
International Sponsor
GlaxoSmithKline
Principal Investigators for Canadian Sites
AYA:
McGill University Health Centre - Dr. Saleh
Princess Margaret Cancer Centre (AYA) - Dr. Razak
Centres
Medical contact

Dr. Albiruni Razak

albiruni.razak@uhn.ca

Social worker/patient navigator contact

N/A

Clinical research contact

Jasmine Lee

jasmine.lee@uhn.ca

Medical contact

Sarcoma-Dr. Jonathan Noujaim 

jonathan.noujaim.med@ssss.gouv.qc.ca

Sarcoma-Dr. Ramy Saleh    

 ramy.saleh@mcgill.ca

Social worker/patient navigator contact

N/A

Clinical research contact

Sarcoma - Mahafarin Maralani

mahafarin.maralani@muhc.mcgill.ca

 

 

Study Description

The main goal of this study is to test a new medicine called Risvutatug Rezetecan (Ris-Rez). Researchers want to find out if it can help treat certain types of cancer, if it is safe, how well people tolerate it, and how the body absorbs and breaks down the medicine. This study is for teenagers and adults with osteosarcoma, a type of bone cancer, or soft tissue sarcoma, a type of cancer that starts in soft tissues like muscles, fat, or nerves.

Inclusion Criteria
  • Participants must be 12 years of age or older
  • Participants must have osteosarcoma (bone cancer) or a soft tissue sarcoma that cannot be removed with surgery or has spread to other parts of the body
  • Recent scans must show that the cancer has continued to grow despite the most recent treatment.
  • Participants should be well enough to carry out most daily activities and their overall health should have remained stable during the two weeks before starting the study.
  • Participants must meet organ and lab function requirements 
  • Participants (or a parent/legal guardian) must read, understand, and sign a consent form and agree to follow the study requirements before joining.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

CONNECT2110 - A Phase II Trial of ACT001 in Children and Adolescents With Diffuse Intrinsic Pontine Gliomas and H3K27-altered High Grade Gliomas

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CONNECT2110 - A Phase II Trial of ACT001 in Children and Adolescents With Diffuse Intrinsic Pontine Gliomas and H3K27-altered High Grade Gliomas

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DiagnosisDiffuse Intrinsic Pontine Gliomas (DIPG), H3K27-altered High Grade GliomaStudy StatusOpen
PhaseII
Age12 Months to 39 YearsRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: ACT001 (Oral, twice a day)
Last Posted Update2026-07-22
ClinicalTrials.gov #NCT06838676
International Sponsor
Nationwide Children's Hospital
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Anirban Das
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

 This study is eligible for STEP-1 funding. Find more information here. 

This research study will investigate how safe and effective a drug called ACT001 is in patients with either Diffuse Intrinsic Pontine Gliomas (DIPG) or High-Grade Gliomas (with a H3K27 genetic alteration.)

Inclusion Criteria
  • Ages 12 months to 39 years old
  • Cohort A: Newly diagnosed DIPG (Diffuse Intrinsic Pontine Gliomas)
  • Cohort B: DIPG or H3K27-altered HGG (High Grade Glioma) that came back, got worse, or didn’t respond to other treatment
  • Must be able to do at least half of normal daily activities
  • Cohort B must be recovered from past treatment side effects and follow required waiting times after chemo, immunotherapy, or radiation
  • Must have healthy bone marrow, kidneys, liver, and heart
  • Must meet all bloodwork requirements
  • Seizures must be controlled; neurologic problems must be stable
  • Must be at least 3 months after autologous stem cell transplant; no allogeneic transplants allowed

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

MK-9999-01A/​LIGHTBEAM-U01 - LIGHTBEAM-U01 Substudy 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors

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MK-9999-01A/​LIGHTBEAM-U01 - LIGHTBEAM-U01 Substudy 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors

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DiagnosisB-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma, Burkitt Lymphoma, Neuroblastoma, Ewing SarcomaStudy StatusOpen
PhaseI/II
Age6 Months to 25 YearsRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationBiological: Zilovertamab vedotin (IV) Other Names: MK-2140, VLS-101
Last Posted Update2026-06-02
ClinicalTrials.gov #NCT06395103
International Sponsor
Merck Sharp & Dohme LLC
Principal Investigators for Canadian Sites
Montreal Children's Hospital - Dr. Catherine Vézina
The Hospital for Sick Children - Dr. Daniel Morgenstern
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 study is part of a larger research project. The goal is to see if a new treatment called zilovertamab vedotin is safe and works well for children and young adults whose cancer has come back (relapsed) or did not get better with treatment (refractory).

The study is for patients with B-ALL (a type of leukemia that starts in the bone marrow and blood), DLBCL or Burkitt lymphoma (fast-growing blood cancers that affect the lymph nodes or organs), neuroblastoma (a cancer that starts in nerve cells, usually in young children), or Ewing sarcoma (a cancer of the bones or nearby tissue, often in children and teens).

Inclusion Criteria
  • Participant must have one of the following diagnoses:
    • Blood cancers: children with a type of leukemia called B-ALL and children with certain fast-growing lymphomas (DLBCL or Burkitt lymphoma) OR
    • Solid tumors: children with neuroblastoma or children with Ewing sarcoma

Other inclusion or exclusion criteria may apply and will be discussed with you by the study team. 

DCL-17-001 - An Open-Label, Dose Escalation, Efficacy, and Safety Study of CLR 131 in Children and AYA with Select Solid Tumors, Lymphoma, and Malignant Brain Tumors (CLOVER-2) and Expansion in Children, AYA with Relapsed or Refractory High Grade Glioma

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DCL-17-001 - An Open-Label, Dose Escalation, Efficacy, and Safety Study of CLR 131 in Children and AYA with Select Solid Tumors, Lymphoma, and Malignant Brain Tumors (CLOVER-2) and Expansion in Children, AYA with Relapsed or Refractory High Grade Glioma

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DiagnosisGlioblastoma, Astrocytoma, Oligodendroglioma, Mixed Glioma, Pleomorphic Xanthoastrocytoma, Ganglioglioma, DIPG, Ependymoma Study StatusCompleted
PhaseI/II
AgeChild, Adult - (10 years to 25 years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationCLR 131 administered intravenously, fractionated dose Arm 1: two planned cycles, 20 mCi/m2 on day 1 and day 15 Arm 2: three planned cycles, 10mCi/m2 on day 1 and day 15
Last Posted Update2026-05-28
ClinicalTrials.gov #NCT03478462
International Sponsor
Cellectar Biosciences, Inc.
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This clinical trial studies the side effects of a medication called CLR131. This medication is a targeted radiopharmaceutical, which means it acts like radiation therapy, but is given intravenously as an infusion. 

CLR 131 is designed to target cells with cancer rather than cells without cancer. The main goal of this study is to determine what is the safe amount of medication to give to children with cancer that has come back or is not responding to treatment.

 

Inclusion Criteria
  • Age between 10 and 25 years
  • High Grade Glioma that has come back (relapse) or not improved despite treatment (progression)
  • Must meet all bloodwork requirements
  • Patient must be up and about at least 60% of their waking hours
  • Patient must be willing to comply with study visit requirements and sign a consent form 

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