Canadian clinical trial registry

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Study Description

This study looks to assess if additional intensive treatment for patients with medulloblastoma and other embryonal brain tumors improves outcomes without adding significant short or long-term side effects. 

Inclusion Criteria

Patients 10 years of age of less with a diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord. Any stage of medulloblastoma or CNS embryonal tumor in children less than 6 years old are eligible, whereas only high risk patients from 6-10 years of age are eligible. 

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 selpercatinib (a medication taken by mouth) works in treating patients with solid tumors and brain tumours with a change in a gene called RET. 

Selpercatinib may stop the growth of cancer cells with RET gene changes by blocking the RET enzymes needed for cell growth.

Inclusion Criteria

• Age between 6 months and 21 years
• Solid tumors and brain tumours with a change in a gene called RET
• Cancer that has come back (relapse) or is not improving despite treatment (progression)
• 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 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.

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Study Description

(via: https://www.mskcc.org/cancer-care/clinical-trials/21-303)

The purpose of this study is to find the highest dose of the investigational drug RP-6306 that can be used in advanced solid tumors containing certain genetic changes and which have come back or continued to grow despite prior treatment. 

RP-6306 blocks the protein PKMY1, which plays a major role in the survival and growth of cancers with the genetic changes being studied in this clinical trial. RP-6306 is taken orally (by mouth).

Inclusion Criteria

(via: https://www.mskcc.org/cancer-care/clinical-trials/21-303)

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have a locally advanced or metastatic solid tumor that has come back or continued to grow despite prior treatment
• Participants’ tumors must contain a mutation in the FBXW7 or PPP2R1A genes or extra copies of the CCNE1 gene
• Patients must be able to walk and do routine activities for more than half of their normal waking hours
• This study is for people age 12 and older

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

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Study Description

Some diseases such as cancer with BRAF mutations, low grade gliomas and plexiform neurofibroma in patients with neurofibromatosis type 1 [NF-1], or Langerhans cell histocytosis [LCH]) have been shown to have molecular dysfunction called MAPK pathway dysregulation which favors tumour development. The MAPK pathway is involved in cell growth, differentiation, inflammation and apoptosis.Trametinib is an inhibitor of components of the MAPK pathway called MEK1 and MEK2. Drabafenib is a small molecule that inhibits the MAPK pathway in BRAF mutated cells by blocking the BRAF serine-threonine kinase. Both are expected to slow or stop the growth of cancer cells.

The aim of this phase I/II study is to evaluate the dose, safety, tolerability, antitumor activity and other pharmacologic characteristics of Trametinib alone or with Dabrafenib in children with refractory or relapsed solid cancer or disease with BRAF mutations for which no standard therapy is available or for which the subject is not eligible for the existing therapy.

The study is currently open for LCH and neuroblastoma only.

Inclusion Criteria

• Male or female between one month and <18 years of age (inclusive) at the time of signing consent
• Must have a disease that is relapsed/refractory to all potentially curative standard treatment regimens or must have a current disease for which there is no known curative therapy, or therapy proven to prolong survival with an acceptable quality of life.
• The subject's disease (i.e. cancer, neurofibromatosis type 1 [NF-1] with plexiform neurofibroma [PN], or Langerhans cell histocytosis [LCH]) must have relapsed after or failed to respond to frontline curative therapy or there must not be other potentially curative treatment options available. Curative therapy may include surgery, radiation therapy, chemotherapy, or any combination of these modalities
• Able to swallow and retain enterally administered medication

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 larotrectinib (a medication taken by mouth) works in treating patients with

• solid tumors and brain tumours with a specific gene change called a "TRK fusion", previously untreated
• acute leukemia that has come back, and has a specific gene change called a "TRK fusion".

Larotrectinib may stop the growth of cancer cells with TRK fusions by blocking the TRK enzymes needed for cell growth.

Inclusion Criteria

• Age up to 30 years
• Patients must fit into one of the 3 groups
  • Group A: diagnosis of infantile fibrosarcoma with a specific gene change called a "TRK fusion". The patient will have received no prior anti-cancer therapy, including radiotherapy, other than surgical resection (operation to remove the tumour)
  • Group B: diagnosis of any solid tumor including brain tumours (except high grade gliomas), with a specific gene change called a "TRK fusion". The patient will have received no prior anti-cancer therapy, including radiotherapy, other than surgical resection (operation to remove the tumour)
  • Group C: diagnosis of acute leukemia that has come back, and has a specific gene change called a "TRK fusion".
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

Some cancer, called hypermutant cancer, have been shown to have multiple genetic changes  or abnormalities that block DNA repair and favor tumour development. 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 immune system to help it identify and destroy the cancer cells. It is expected to slow or stop the growth of cancer cells.

In this phase I/II study, patients will not be randomized and all enrolled on the clinical trial will receive nivolumab.  The study will evaluate the dose, safety, tolerability, effect on the cancer and other important characteristics of nivolumab.  This study includes pediatric patients with recurrent or refractory hypermutant cancer aged 12 months to 18 years, including those with  bMMRD syndrome. for which no standard therapy is available or for which the subject is not eligible for the existing therapy.

Inclusion Criteria

•    Patients must be greater than 2 months and less than 25 years of age at time of enrollment. Please note, some hospitals may not be able to treat patients above certain ages (e.g., 18 years old).
•    Recurrent or relapse paediatric cancer suspected to be hypermutant, including those exhibiting evidence of genetic or molecular alterations such as: high microsatellite instability (MSI-H) in current or previous tumour, mutation causing loss of mismatch repair gene (MLH1, MSH2, MSH6, PMS2, EPCAM or MSH3) expression, hypermutation by local sequencing in current or previous tumour, a history of CMMRD, Lynch syndrome, xeroderma pigmentosum (XP), or other established disorder affiliated with an elevated hypermutation rate, a functional mutation of polymerase genes (POLE or POLD1) in current or previous tumour, a functionally impaired RRD pathway by other means; etc. 
•    Patients must have histologic or cytologic confirmation of malignancy at the time of initial diagnosis or relapse (as specified above). Patients with multiple concurrent and/or sequential neoplasms are eligible, including CNS and haematological malignancies.
•    Patients must be able to provide tumour sample (archival or a new biopsy). If a tumour sample (including archival) is not available, a new tumour sample may be needed. Any such biopsy will not be considered a trial-related procedure.

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

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Study Description

Some rare cancer such as rhabdoid tumors or epithelioid sarcoma have been shown to have a molecular dysfunction allowing a protein called EZH2 to favour tumour developpment. Tazemetostat is an EZH2 inhibitor and is expected to slow or stop the growth of cancer cells. The aim of this Phase I study is to evaluate the dose, safety, tolerability, antitumor activity and other pharmacologic characteristics of Tazemetostat in children with refractory or relapsed solid cancer  for which no standard therapy is available or for which the subject is not eligible for the existing therapy. 

Inclusion Criteria

• Age ≥6 months to <18 years
• Patient has one of the specific disease targeted in this study, histologically confirmed by a CLIA/CAP certified laboratory
• Relapsed or refractory disease and no standard treatment options as determined by locally or regionally available standards of care and treating physician's discretion
• Patient is able to swallow and retain orally administered medication

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