1. Registre canadien des essais cliniques
  2. Registre canadien des essais cliniques

Registre canadien des essais cliniques

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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

114 results found

Title
Status

 

BCC021 - Phase I/II Study of Silmitasertib (CX-4945) in Combination With Chemotherapy in Children and Young Adults With Relapsed Refractory Solid Tumors

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BCC021 - Phase I/II Study of Silmitasertib (CX-4945) in Combination With Chemotherapy in Children and Young Adults With Relapsed Refractory Solid Tumors

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DiagnosisRecurrent Neuroblastoma, Ewing's Sarcoma, Osteosarcoma, Rhabdomyosarcoma, LiposarcomaStudy StatusOpen
PhaseI/II
Ageup to 30 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Silmitasertib (Oral) Other Names: CX-4945 Drug: Irinotecan (IV) Drug: Temozolomide (Oral) ± Drug: Vincristine (IV)
Last Posted Update2026-02-18
ClinicalTrials.gov #NCT06541262
International Sponsor
Milton S. Hershey Medical Center
Principal Investigators for Canadian Sites
CHU Ste-Justine - Dr. Monia Marzouki
Centres

Aucun centre rattaché

 

 

Study Description

 

The purpose of this study is to learn more about how safe and effective a drug called silmitasertib (an oral pill) is in combination with other FDA approved chemotherapy drugs to treat certain kinds of solid tumours. 

Inclusion Criteria
  • Participants must be 30 years or younger
  • A confirmed tumor type of Neuroblastoma, Ewing sarcoma, Osteosarcoma, Rhabdomyosarcoma, or Liposarcoma that has come back or not responded to standard treatment
  • Doctors must be able to see signs of cancer on a scan or in the bone marrow
  • Must have recovered from past treatments, with enough time passed since chemo, radiation, immunotherapy, or transplant
  • Must meet all organ function and bloodwork requirements
  • Must be up and about for 50% of waking hours
  • If patient can become pregnant, a negative pregnancy test and adequate birth control is required
  • Signed informed consent

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 Update2026-01-22
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
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

 

 

 

Study Description

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. 

ARST2031 - A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance in Patients With High Risk Rhabdomyosarcoma (HR-RMS)

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ARST2031 - A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance in Patients With High Risk Rhabdomyosarcoma (HR-RMS)

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DiagnosisRhabdomyosarcomaStudy StatusClosed
PhaseIII
Ageup to 50 YearsRandomisationYES
Line of treatmentFirst line treatment
Routes of Treatment AdministrationChemotherapy medications (Cyclophosphamide, Dactinomycin, Vincristine, Vinorelbine), all given intravenously, except for cyclophosphamide that will be taken by mouth too Patients will also receive radiation therapy when participating to this study.
Last Posted Update2026-01-20
ClinicalTrials.gov #NCT04994132
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Paul Nathan
Hamilton Health Sciences Centre - Dr. Uma H. Athale
Children’s Hospital of Eastern Ontario (CHEO) - Dr. Donna L. Johnston
Children's Hospital of Western Ontario – Dr. Shayna Zelcer

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. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
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. Alexandra Zorzi
Dr. Shayna Zelcer
 
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
 
Clinical research contact
Mariam Mikhail

 

 

Study Description

This phase III trial compares the effect of two chemotherapy drug pathways (vinorelbine with vincristine, dactinomycin, and cyclophosphamide (VAC) followed by vinorelbine and cyclophosphamide versus VAC followed by vinorelbine and cyclophosphamide) for the treatment of high risk rhabdomyosarcoma.

Chemotherapy drugs, such as vinorelbine, vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Giving vinorelbine and VAC may kill more tumor cells and adding maintenance therapy after VAC therapy may help get rid of the cancer and/or lower the chance that the cancer comes back.

Inclusion Criteria
  • Patients must be =< 50 years of age 
  • Study is open to all genders
  • Patients with newly diagnosed rhabdomyosarcoma (RMS) of any subtype, meeting "high risk" criteria
  • Various bloodwork (bilirubin, creatinine, etc) must be within an acceptable range
  • Patients must not be pregnant during the duration of the trial
  • Additional inclusion and exclusion criteria may apply and will be reviewed by the study team

AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Closed to enrollment

More information

AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

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DiagnosisHepatocellular Carcinoma, Malignant Liver Neoplasm, Fibrolamellar Carcinoma, Hepatoblastoma Study StatusClosed to enrollment
PhaseII/III
AgeChild, Adult - (up to 30 Years)RandomisationYES
Line of treatmentFirst line treatment
Routes of Treatment AdministrationCisplatin: IV, Other drugs are given as usually administered for hepatoblastoma/liver cancer therapy
Last Posted Update2026-01-20
ClinicalTrials.gov #NCT03533582
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Victor A. Lewis
University of Alberta Hospital (Not Affiliated with U-Link) - Dr. Sarah J. McKillop
CancerCare Manitoba - Dr. Ashley Chopek
IWK Health Centre - Dr. Craig Erker
Hamilton Health Sciences Centre, McMaster University - Dr. Uma H. Athale
Cancer Centre of Southeastern Ontario at Kingston General Hospital - Dr. Laura Wheaton
Children's Hospital of Western Ontario - Dr. Shayna M. Zelcer
The Hospital for Sick Children - Dr. Furqan Shaikh
Montreal Children's Hospital - Dr. Sharon B. Abish
CHU Ste-Justine - Dr. Yvan Samson
CHU de Quebec - Dr. Bruno Michon
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
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. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
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. 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
 

 

 

 

Study Description

This trial studies how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy after surgery may kill more tumor cells.


Inclusion Criteria
  • Patients must be newly diagnosed with hepatic malignancies (liver cancers) such as hepatoblastoma or hepatocellular carcinoma
  • Patients must be under 30 years of age 
  • All patients and/or their parents or legal guardians must sign a written informed consent

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 Update2026-01-08
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
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

 

 

 

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. 

BCC016 - Phase II Trial of Eflornithine/DFMO as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma

Open

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BCC016 - Phase II Trial of Eflornithine/DFMO as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma

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DiagnosisMedulloblastomaStudy StatusOpen
PhaseII
Ageup to 21 YearsRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: Difluoromethylornithine (Oral) Other Names: Eflornithine, DFMO
Last Posted Update2025-12-04
ClinicalTrials.gov #NCT04696029
International Sponsor
Giselle Sholler
Principal Investigators for Canadian Sites
CHU Quebec - Dr. Bruno Michon
Centres
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

 

 

Study Description

Participants with a diagnosis of a brain tumour called medulloblastoma (categorized as high risk/very high risk or has not responded to previous treatment) will receive an oral dose of a medication called difluoromethylornithine (DFMO) twice a day while on study. 

Inclusion Criteria
  • Must be 21 years old or younger to participate
  • Have a confirmed diagnosis of medulloblastoma that has been categorized as high risk/very high risk or has not responded to previous treatment
  • A disease assessment that includes imaging, lumbar puncture (only if previously positive) and bone marrow aspiration biopsy (only if previously positive) will be done
  • Must have had enough time pass from any prior therapy (60 days from last dose of conventional chemotherapy and 45 days for high dose chemotherapy + stem cell transplantation)
  • Participants must be up and about for at least 50% of waking hours
  • Must meet all requirements for organ function, clinical and laboratory tests
  • Females of childbearing potential must have a negative pregnancy test and must agree to use an effective birth control method.
  • Participants or their legal representatives must sign an informed consent 

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

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

Open

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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 Update2025-12-04
ClinicalTrials.gov #NCT04301843
International Sponsor
Giselle Sholler
Principal Investigators for Canadian Sites
Montreal Children's Hospital – Dr. Jitka Stankova
CancerCare Manitoba – Dr. Ashley Chopek
CHU Ste-Justine – Dr. Pierre Teira
CHU Sherbrooke - Dr. Josée Brossard
Alberta Children's Hospital – Dr. Melanie Finkbeiner
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. Josee Brossard 
Social worker/patient navigator contact
Please Contact Site Directly
 
Clinical research contact
Please Contact Site Directly 
 
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.

 

BCC018 - A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Open

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BCC018 - A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

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DiagnosisHigh-risk NeuroblastomaStudy StatusOpen
PhaseII
Age12 Months to 21 YearsRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationDrug: Naxitamab (Intravenous (IV)) Additionally for patients with ALK aberration: Drug: Ceritinib (Oral)
Last Posted Update2025-12-04
ClinicalTrials.gov #NCT05489887
International Sponsor
Wake Forest University Health Sciences
Principal Investigators for Canadian Sites
CHU Quebec - Dr. Bruno Michon
CHU Ste Justine - Dr. Pierre Teira
CHU Sherbrooke - Dr. Josée Brossard
Centres
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

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. Josee Brossard 
Social worker/patient navigator contact
Please Contact Site Directly
 
Clinical research contact
Please Contact Site Directly 
 

 

 

Study Description

This is a Phase 2 trial for newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of combining the drug naxitamab with standard induction therapy. Initially, there will be 5 cycles of standard chemotherapy with Naxitamab on days 1, 3 and 5 of each cycle. Patients with an ALK mutation or amplification will have the drug ceritinib added to their treatment regimen as soon as results are available. 

Inclusion Criteria
  • Subjects must have a diagnosis of neuroblastoma or ganglioneuroblastoma that meets criteria
  • Subjects must be age ≤ 21 years at initial diagnosis
  • Subjects must be >12 months of age at enrollment
  • Subject's bloodwork must be within acceptable study ranges
  • Pregnant subjects are not eligible for this study, a negative serum pregnancy test is required for female participants of childbearing potential
  • Both male and female study subjects who have reached puberty must be willing to use a highly effective contraceptive method, these methods will be discussed with you by the study team
  • All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.
  • Subjects enrolled on study must complete all required assessments