Canadian clinical trial registry

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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.

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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

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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

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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

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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.

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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

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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