Canadian clinical trial registry

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Study Description

This is a study of trametinib (an oral drug called a MEK inhibitor) in children and adolescents who have any of the following types of cancer or tumours:

- patients with neurofibromatosis type 1 (NF1) that have low grade glioma, or
- patients with neurofibromatosis type 1 (NF1) that have plexiform neurofibroma,
- patients with low grade glioma that has a gene change called a BRAF fusion (in the tumour)
- patients with glioma of any grade (low or high) with activation of proteins called the MAPK/ERK pathway.

For all patients (except for those with plexiform neurofibroma), the disease must have recurred or grown in size after a first treatment.

Inclusion Criteria

• Patient must be aged ≥ 1 month (corrected age) to ≤ 25 years at the time of study enrollment
• Participants must belong to one of the groups described in the study description section
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

Publications

Perreault S, Larouche V, Tabori U, Hawkin C, Lippé S, Ellezam B, Décarie JC, Théoret Y, Métras MÉ, Sultan S, Cantin É, Routhier MÈ, Caru M, Legault G, Bouffet É, Lafay-Cousin L, Hukin J, Erker C, Jabado N. A phase 2 study of trametinib for patients with pediatric glioma or plexiform neurofibroma with refractory tumor and activation of the MAPK/ERK pathway: TRAM-01. BMC Cancer. 2019 Dec 27;19(1):1250. doi: 10.1186/s12885-019-6442-2.

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Study Description

This clinical trial studies the side effects and how well entrectinib (a medication taken by mouth) works in treating patients with solid tumors and brain tumours with a specific gene change called a "NTRK fusion" or a "ROS1 fusion". Entrectinib may stop the growth of cancer cells with NTRK or ROS1 fusions by blocking the TRK or ROS1 enzymes needed for cell growth.

Inclusion Criteria

• Age up to 18 years
• Solid tumors and brain tumours with a change in a called a NTRK1/2/3 fusion or a ROS1 fusion
• 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

Publications

Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11. Erratum in: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341. Lancet Oncol. 2020 Aug;21(8):e372.

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Study Description

In this study, researchers are trying to learn more about the safety of the combination of study medicines Avelumab and Lenvatinib, and how well they work for children and young people with central nervous system tumours where previous treatment have not worked.

If you/your child participate in this study, you/they will be asked to join one of the two parts.

Part 1 will help us learn the best dose of the drug to take, and in Part 2, we will use the information obtained in Part 1 to continue to give the study drug and monitor how it is working.

Inclusion Criteria

• Patients must have a confirmed diagnosis of a high-grade brain tumour
• Patients must be between the ages of 2-18 years old
• Patients must have a cancer that has come back (relapsed) after a previous treatment
• Patients must be able to walk and do routine activities for more than half of their normal waking hours
• Patients must have a willingness to complete clinical assessments throughout the study (electronic, paper and/or interviewer methods)

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

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Study Description

Some solid tumours and some brain tumours shares common a common feature that is called "deregulation of the ErbB-pathway". Afatinib is an drug, taken by mouth, that can block proteins from the ErbB-family and could be efficient in pediatric tumours with Erb pathway deregulation. 

The aim of this study is to find the maximum tolerated dose of afatinib, and to assess its activity against tumours.

Inclusion Criteria

• Paediatric patients aged 1 year to <18 years at the time of informed consent
• Diagnosis of HGG, DIPG, low grade astrocytoma, medulloblastoma/PNET, ependymoma, neuroblastoma, RMS and tumours with ErbB deregulation
• Recurrent/refractory disease after they received at least one prior standard treatment regimen
• No effective conventional therapy exists

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

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Study Description

(Translated from summary in French available on u-link.eu for the same study)

Gliomas are the most common brain tumors in children. They are classified into two groups: low-grade gliomas common in younger people and high-grade malignant gliomas that affect older children or adolescents. Genetic studies of these tumors have made it possible to highlight specific mutations which open the opportunity to new therapeutic avenues when standard treatments have not been effective.

In this protocol a combination of two drugs is used:

• Dabrafenib blocks a cellular process necessary for cell proliferation (it is a BRAF inhibitor)
• Trametinib blocks another process necessary for cell proliferation (it is a MEK inhibitor)

This study explores the efficacy and tolerance of these two new medications taken together.

Their association is studied on the two groups of glioma as follows:

• For children with high-grade glioma who have not responded to the standard treatment, the two molecules are taken orally every day.
• For children with low-grade glioma, the children are divided into 2 groups by drawing lots (randomization):
  • The first group receives the two molecules orally every day.
  • The second group receives classical chemotherapy (vincristine and carboplatin) according to standard of care. If the disease progresses despite these treatments, patient will be able to receive the two molecules tested
• In all cases the tumour will need to have a marker called BRAF V600 for the child to be considered for this study

Inclusion Criteria

(Translated from summary in French available on u-link.eu for the same study)

• Child aged 1 to 18
• Low or high grade glioma to whom standard treatments have not produced a sufficient response or who have relapsed.
• In all cases the tumour will need to have a marker called BRAF V600 for the child to be considered for this study
• 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 chemotherapy called azacitidine in addition to the standard chemotherapy in infants diagnosed with acute lymphoblastic leukemia with a certain mutation called KMT2A-rearrangement.

Enrolled patients will receive four courses of azacitidine during their treatment. The study also looks at the side effects associated with these medications.

Inclusion Criteria

• Children less than 1 year of age
• New diagnosis of acute lymphoblastic leukemia
• Presence of a change called "KMT2A-rearrangement" in the leukemia cells

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 two drugs (bortezomib and vorinostat) in addition to standard therapy, for the treatment of infants with a new diagnosis of acute lymphoblastic leukemia. 

The study also looks at the side effects associated with these medications.

Bortezomib is a drug called a "proteasome inhibitor" while vorinostat is a drug called an "HDAC inhibitor".

Inclusion Criteria

• Children younger than 365 days of age with a new diagnosis of acute lymphoblastic leukemia
• They cannot have had prior treatment with other chemotherapies (with exception of a few medications, with limited amount of doses given).
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

The reason for this study is to see if the study medication LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma (neuroblastoma that has come back or is not improving despite treatment). LY3295668 erbumine blocks a protein called Aurora kinase A. Aurora kinase A is thought to contribute to the aggressiveness of neuroblastoma cells. 

The medication will be given either alone or in combination with chemotherapy.

Inclusion Criteria

• Age between 2 and 21 years
• Neuroblastoma that has come back (relapse) or is not improving despite treatments (refractory)
• The child must be able to swallow capsules
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team