Canadian clinical trial registry

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

71 results found

Title
Status

 

PLAT-05 - Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-05: A Phase 1 Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia

Open

PLAT-05 - Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-05: A Phase 1 Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia

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DiagnosisLeukemia, ALL, Acute Lymphoblastic LeukemiaStudy StatusOpen
PhaseI
AgeChild, Adult - (up to 30 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIV
Last Posted Update2021-10-18
ClinicalTrials.gov #NCT03330691
International Sponsor
Seattle Children's Hospital
Principal Investigators for Canadian Sites
BC Children's Hospital – Dr. Kirk Schultz
Centres
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

 

 

Study Description

Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and some patients who relapse following CD19 directed therapy relapse with CD19 negative leukemia. For this reason, the investigators are attempting to use T-cells obtained directly from the patient, which can be genetically modified to express two chimeric antigen receptors (CARs). One is to recognize CD19 and the other is to recognize CD22, both of which are proteins expressed on the surface of the leukemic cell in patients with CD19+CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through recognition of CD19 and CD22. This is a phase 1 study designed to determine the safety of the CAR+ T-cells and the feasibility of making enough to treat patients with CD19+CD22+ leukemia.

Inclusion Criteria
  • First 2 subjects: male and female subjects age ≥18 and < 27 years (as of 2/16/18 the first 2 subjects were enrolled and treated); subsequent subjects: male and female subjects age ≥12 months of age and <27 years.
  • Diagnosis of CD19+22+ leukemia relapsed or refractory
  • Asymptomatic from CNS involvement
  • Free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks prior to enrollment
  • Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy
  • No prior genetically modified cell therapy that is still detectable or virotherapy
  • Willing to participate in long-term follow-up for up to 15 years, if enrolled in the study and receive T cell infusion

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

CFZ008 - Phase 1b Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

Open

CFZ008 - Phase 1b Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

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DiagnosisAcute Lymphoblastic LeukemiaStudy StatusOpen
PhaseI
AgeChild, Adult - (1 Year to 21 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment Administrationintravenous (carfilzomib); Other drugs as usually administered for leukemia therapy
Last Posted Update2021-09-03
ClinicalTrials.gov #NCT02303821
International Sponsor
Amgen
Principal Investigators for Canadian Sites
CHU Ste-Justine - Dr. Henrique Bittencourt

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 is trying to determine how much carfilzomib (an anti-cancer drug) should be used, alone and in combination with induction chemotherapy, to treat children with acute lymphoblastic leukemia that has come back (relapsed) or is refractory to treatment. Carfilzomib is an anti-cancer medication called proteasome inhibitor and is given intravenously.

 

Inclusion Criteria
  • Age 1 year to 21 years
  • Acute lymphoblastic leukaemia 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

201 - A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Open

201 - A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

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DiagnosisNeuroblastomaStudy StatusOpen
PhaseII
AgeChild, Adult, Older Adult - (1 Year and older)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment Administrationnaxitamab (intravenous); GM-CSF (sub-cutaneous)
Last Posted Update2021-09-03
ClinicalTrials.gov #NCT03363373
International Sponsor
Y-mAbs Therapeutics
Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

NAIT Program 

nait.info@sickkids.ca

 

 

 

Study Description

This is a study of naxitamab, also known as hu3F8, a humanised antibody targeting GD2 in children and adults diagnosed with high-risk neuroblastoma. GD2 is a marker present at the surface of the neuroblastoma cells; therefore the naxitamab can target the neuroblastoma cells and stimulate the immune system to kill them.

Patients with with primary refractory disease (disease that has never improved with previous treatment), or patients that have had a relapse but incomplete response of the disease in bone and/or bone marrow from salvage treatment will be considered for this study.

Granulocyte-macrophage colony stimulating factor (GM-CSF) will be given along naxitamab.

Inclusion Criteria
  • Diagnosis of high-risk neuroblastoma with disease in bone and/or bone marrow.
  • High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

N2011-01 - NANT 2011- 01: Randomized Phase II Pick the Winner Study of 131I-MIBG, 131I-MIBG With Vincristine and Irinotecan, or 131I-MIBG With Vorinostat for Resistant/Relapsed Neuroblastoma

Closed to enrollment

N2011-01 - NANT 2011- 01: Randomized Phase II Pick the Winner Study of 131I-MIBG, 131I-MIBG With Vincristine and Irinotecan, or 131I-MIBG With Vorinostat for Resistant/Relapsed Neuroblastoma

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DiagnosisNeuroblastomaStudy StatusClosed to enrollment
PhaseII
AgeChild, Adult - (2 Years to 30 Years)RandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationVorinostat (oral); vincristine, irinotecan and 131I-MIBG are given intravenously.
Last Posted Update2021-09-03
ClinicalTrials.gov #NCT02035137
International Sponsor
New Approaches to Neuroblastoma Therapy Consortium
Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Meredith Irwin
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

NAIT Program 

nait.info@sickkids.ca

 

 

 

Study Description

This study is specifically for patients diagnosed with relapsed or persistent neuroblastoma.

Metaiodobenzylguanidine (MIBG) is a compound that can be combined with radioactive iodine (I-131) to deliver targeted radiation therapy. Oncologists use to deliver targeted radiation to neuroblastoma. I-131 MIBG is administered to a child through an intravenous line and is absorbed by tumor cells, which are killed by radiation emitted by the radioactive I-131. 

The three treatment arms are the following:

  • 131 I-MIBG therapy alone
  • 131 I-MIBG therapy with Irinotecan and Vincristine: The two chemotherapy medications irinotecan and vincristine, which are known to be active agents for neuroblastoma, are given at the same time as the 131I-MIBG, and may make the 131I-MIBG more effective at treating neuroblastoma.
  • 131 I-MIBG with Vorinostat: Vorinostat is a drug that is FDA-approved to treat a certain type of cancer mainly seen in adults. Vorinostat affects the way the DNA that carries our genes is folded in cells. In the laboratory, vorinostat causes neuroblastoma cells to stop growing. This effect is even greater when vorinostat is combined with radiation. Giving vorinostat together with the 131I-MIBG may make the 131I-MIBG more effective at treating neuroblastoma.

Why is this study being done?

  • To find out which of the three 131I-MIBG treatment arms have a better tumor response rate
  • To compare the side effects seen with 131I-MIBG alone, compared with 131I-MIBG in combination with Vincristine and Irinotecan or  131I-MIBG with Vorinostat.
  • To describe the number of patients found to have tumor cells in the blood and bone marrow using a new sensitive test following each of the three 131I-MIBG treatment arms.
  • To compare the exposure of whole body radiation from 131I-MIBG received on the three treatment arms.
  • To learn about a new computerized way of reading MIBG scans.
Inclusion Criteria

(From NANT website - https://www.nant.org/n2011-01/)

  • Patients must be at least 24 months and no older than 30 years of age
  • Patients must have relapsed neuroblastoma, refractory neuroblastoma or persistent neuroblastoma 
  • Patients must have  at least one site of tumor with MIBG uptake based on an MIBG scan done within 4 weeks prior to entry on study
  • Patients must have an adequate number of  peripheral blood stem cells available.
  • Patients must have adequate organ function.
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

ADVL1412 - A Phase 1/2 Study of Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors as a Single Agent and in Combination With Ipilimumab

Completed

ADVL1412 - A Phase 1/2 Study of Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors as a Single Agent and in Combination With Ipilimumab

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Diagnosissolid tumors, Ewing Sarcoma, osteosarcoma, neuroblastoma, PNET, rhabdomyosarcoma, Hodgkin lymphoma, non-Hodgkin lymphoma, melanomaStudy StatusCompleted
PhaseI/II
AgeChild, Adult - (12 Months to 30 Years )RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationNivolumab - IV
Last Posted Update2021-09-03
ClinicalTrials.gov #NCT02304458
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

NAIT Program 

nait.info@sickkids.ca

 

 

 

Study Description

Nivolumab is a type of therapy called immunotherapy that works by attempting to help the body's immune system attack the cancer. This study is to assess the effectiveness of  nivolumab on relapsed or refractory solid tumors in children. The maximum tolerated dose and recommended dose for children will be explored. The study also looks at the side effects associated with this medication. Based on the tumor type, patients are categorized into Parts A through E and receIve nivolumab in recurring cycles. 

 

Inclusion Criteria
  • There are multiple parts to this study. Some parts include children between 1 and 18 years old, while others include patients between 1 and 30 years old
  • Different types of recurrent or refractory solid tumors are included in this study including neuroblastoma, osteosarcoma, rhabdomyosarcoma, Ewing sarcoma, peripheral primitive neuroectodermal tumor (PNET), Hodgkin lymphoma, non-Hodgkin lymphoma and melanoma 
  • Patients with brain tumors or brain metastases from their cancer are not included in this study 
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
Publications

Davis KL, Fox E, Merchant MS, Reid JM, Kudgus RA, Liu X, Minard CG, Voss S, Berg SL, Weigel BJ, Mackall CL. Nivolumab in children and young adults with relapsed or refractory solid tumours or lymphoma (ADVL1412): a multicentre, open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2020 Apr;21(4):541-550. doi: 10.1016/S1470-2045(20)30023-1. Epub 2020 Mar 17.

Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

GO40871 - A Phase I/II, Multicenter, Open-Label, Multi-Arm Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Patients With Relapsed/Refractory Acute Leukemias or Solid Tumors

Open

GO40871 - A Phase I/II, Multicenter, Open-Label, Multi-Arm Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Patients With Relapsed/Refractory Acute Leukemias or Solid Tumors

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DiagnosisAcute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Neuroblastoma, Solid TumorsStudy StatusOpen
PhaseI/II
AgeChild, Adult - (up to 30 Years)RandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIdasanutlin: oral Note: Other drugs are given as usually administered for acute leukemia & solid tumor therapy
Last Posted Update2021-08-31
ClinicalTrials.gov #NCT04029688
International Sponsor
Hoffmann-La Roche
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Aru Narendran
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich

 

 

Study Description

This study seeks to test the safety and effectiveness of the drug taken by mouth called idasanutlin when taken together with chemotherapy or other cancer drugs (venetoclax) to treat acute leukemias or solid tumors in pediatric or young adults. 

The study is divided into 3 parts. The first part of the study aims to figure out the maximum dose of idasanutlin that can be safely tolerated as well as the recommended dose of idasanutlin when used in combination with chemotherapy and other cancer drugs (venetoclax).

The second part of the study aims to test the safety and effectiveness of idasanutlin in combination with chemotherapy and other cancer drugs (venetoclax) for treating neuroblastoma, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL).

The third part of the study further monitors patients for additional responses to idasanutlin and safety assessments.

Inclusion Criteria
  • Age less than 18 years old or less than 30 years old depending on study groups
  • Diagnosis of neuroblastoma, acute myeloid leukemia (AML), or acute lymphoblastic leukemia (ALL) that has worsened or come back despite the use of standard therapy.
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

STEP-RB - Phase I Sustained-Release Topotecan Episcleral Plaque (Chemoplaque) for Retinoblastoma

Open

STEP-RB - Phase I Sustained-Release Topotecan Episcleral Plaque (Chemoplaque) for Retinoblastoma

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DiagnosisRetinoblastoma Study StatusOpen
PhaseI
AgeChild - (up to 17 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationTopotecan - administered using an episcleral plaque (chemoplaque), an implant which contains topotecan (drug). The implant is attached to the outside of the eye and delivers topotecan directly into the eye.
Last Posted Update2021-03-31
ClinicalTrials.gov #NCT04428879
International Sponsor
The Hospital for Sick Children
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

NAIT Program 

nait.info@sickkids.ca

 

 

 

Study Description

This clinical trial studies the side effects and how well a chemoplaque with topotecan (a medication attached to the outside of the eye) works in treating patients with retinoblastoma. This plaque has to be installed and removed under general anesthesia by the ophthalmology team. It delivers the chemotherapy inside the eye.

Inclusion Criteria
  • Age up to 18 years
  • Retinoblastoma in at least one eye
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team