Canadian clinical trial registry

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Study Description

The purpose of this study is to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). NTRK gene changes lead to abnormal proteins called TRK fusion proteins, which may cause cancer cells to grow. Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.

The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug.

The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectinib.

Inclusion Criteria

• Children from birth through 21 years of age
• Patient with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies and for which no standard or available systemic curative therapy exists
• Patient must have a malignancy with a documented NTRK gene fusion.
• Patient with a infantile fibrosarcoma, congenital mesoblastic nephroma or secretory breast cancer Patients with infantile fibrosarcoma, congenital mesoblastic nephroma or secretory breast cancer may enroll into this cohort with documentation of an ETV6 rearrangement or a documented NTRK fusion by next generation sequencing.

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

Publications

Bielack SS, Cox MC, Nathrath M, Apel K, Blattmann C, Holl T, Jenewein R, Klenk U, Klothaki P, Müller-Abt P, Ortega-Lawerenz S, Reynolds M, Scheer M, Simon-Klingenstein K, Stegmaier S, Tupper R, Vokuhl C, von Kalle T. Rapid, complete and sustained tumour response to the TRK inhibitor larotrectinib in an infant with recurrent, chemotherapy-refractory infantile fibrosarcoma carrying the characteristic ETV6-NTRK3 gene fusion. Ann Oncol. 2019 Nov;30 Suppl 8:viii31-viii35. doi: 10.1093/annonc/mdz382. Epub 2019 Dec 24.

Hong DS, DuBois SG, Kummar S, Farago AF, Albert CM, Rohrberg KS, van Tilburg CM, Nagasubramanian R, Berlin JD, Federman N, Mascarenhas L, Geoerger B, Dowlati A, Pappo AS, Bielack S, Doz F, McDermott R, Patel JD, Schilder RJ, Tahara M, Pfister SM, Witt O, Ladanyi M, Rudzinski ER, Nanda S, Childs BH, Laetsch TW, Hyman DM, Drilon A. Larotrectinib in patients with TRK fusion-positive solid tumours: a pooled analysis of three phase 1/2 clinical trials. Lancet Oncol. 2020 Apr;21(4):531-540. doi: 10.1016/S1470-2045(19)30856-3. Epub 2020 Feb 24.

Bielack SS, Cox MC, Nathrath M, Apel K, Blattmann C, Holl T, Jenewein R, Klenk U, Klothaki P, Müller-Abt P, Ortega-Lawerenz S, Reynolds M, Scheer M, Simon-Klingenstein K, Stegmaier S, Tupper R, Vokuhl C, von Kalle T. Rapid, complete and sustained tumour response to the TRK inhibitor larotrectinib in an infant with recurrent, chemotherapy-refractory infantile fibrosarcoma carrying the characteristic ETV6-NTRK3 gene fusion. Ann Oncol. 2019 Nov 1;30(Suppl_8):viii31-viii35. doi: 10.1093/annonc/mdz382.

DuBois SG, Laetsch TW, Federman N, Turpin BK, Albert CM, Nagasubramanian R, Anderson ME, Davis JL, Qamoos HE, Reynolds ME, Cruickshank S, Cox MC, Hawkins DS, Mascarenhas L, Pappo AS. The use of neoadjuvant larotrectinib in the management of children with locally advanced TRK fusion sarcomas. Cancer. 2018 Nov 1;124(21):4241-4247. doi: 10.1002/cncr.31701. Epub 2018 Sep 11.

Laetsch TW, DuBois SG, Mascarenhas L, Turpin B, Federman N, Albert CM, Nagasubramanian R, Davis JL, Rudzinski E, Feraco AM, Tuch BB, Ebata KT, Reynolds M, Smith S, Cruickshank S, Cox MC, Pappo AS, Hawkins DS. Larotrectinib for paediatric solid tumours harbouring NTRK gene fusions: phase 1 results from a multicentre, open-label, phase 1/2 study. Lancet Oncol. 2018 May;19(5):705-714. doi: 10.1016/S1470-2045(18)30119-0. Epub 2018 Mar 29. Erratum in: Lancet Oncol. 2018 May;19(5):e229.

Drilon A, Laetsch TW, Kummar S, DuBois SG, Lassen UN, Demetri GD, Nathenson M, Doebele RC, Farago AF, Pappo AS, Turpin B, Dowlati A, Brose MS, Mascarenhas L, Federman N, Berlin J, El-Deiry WS, Baik C, Deeken J, Boni V, Nagasubramanian R, Taylor M, Rudzinski ER, Meric-Bernstam F, Sohal DPS, Ma PC, Raez LE, Hechtman JF, Benayed R, Ladanyi M, Tuch BB, Ebata K, Cruickshank S, Ku NC, Cox MC, Hawkins DS, Hong DS, Hyman DM. Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children. N Engl J Med. 2018 Feb 22;378(8):731-739. doi: 10.1056/NEJMoa1714448.

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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 phase 2 trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT-driven medulloblastoma.

(via: https://childrensoncologygroup.org/acns1422)

Inclusion Criteria

• Patients are between 3 years to 21 years old
• Patient is newly diagnosed with average-risk medulloblastoma  in the WNT subgroup by institutional diagnosis
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

Philadelphia-like leukemia has specific genetic changes. This study is to assess the dose and effectiveness of an oral medication called ruxolitinib that targets Philadelphia-like leukemia cells. It blocks a protein called JAK. The medication is given in addition to standard therapy for the leukemia. 

Based on the leukemia genetics and initial response to treatment, patients are divided into 4 groups. 

Inclusion Criteria

• Patients between 1 and 21 years of age
• New diagnosis of Philadelphia-like, high-risk B-cell acute lymphoblastic leukemia
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

The purpose of this study is to assess the safety and tolerability of the study drug epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms. The study drug will be given subcutaneously in 28 day cycles and participants will be followed for a minimum of 3 years after enrolling.

Inclusion Criteria

• Participants must have Burkitt's or Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma, or other aggressive mature B-cell lymphomas 
• Tumour must have come back (relapsed) or progressed after previous treatment
• Between 1-18 years of age
• Participants must be able to be up and about at least half of their waking hours
• Adequate organ function 

Other inclusion or exclusion criteria may apply and will be discussed with you by the clinical team

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Study Description

This is a phase II study to treat patients with neuroblastoma that has come back (relapsed) or is not responding to previous treatment (refractory). This study is seeing if combining eflornithine (a drug used to block the production of chemicals that may cause growth of cancer cells) with drugs used in chemotherapy/immunotherapy (irinotecan hydrochloride, temozolomide, sargramostim and dinutuximab) may work better in treating patients with relapsed or refractory neuroblastoma compared to using irinotecan hydrochloride, temozolomide, sargramostim and dinutuximab alone. Patients will be randomly assigned to 1 of 2 regimens, one regimen will recieve eflornithine with the chemotherapy/immunotherapy drugs and the other regimen will recieve chemotherapy/immunotherapy drugs without eflornithine.

Inclusion Criteria

• Patients must have a neuroblastoma that has come back, progressed or not responded to previous treatment
• Patients must be 1 year of age or older
• Patients must be up and about at least 50% of their waking hours
• 14 days must have passed if patients have recieved any treatment that supresses bone marrow
• >= 21 days must have passed from infusion of antibodies
• Patients must not have received radiation for a minimum of 4 weeks before joining the study. Palliative radiation while on study is not permitted.
• Blood work must come back within the acceptable ranges
• Patients must have no evidence of shortness of breath, and no need for supportive oxygen 
• Patients with a history of central nervous system (CNS) disease must have no evidence of active CNS disease at the time of study enrollment
• Patients with seizure disorders may be enrolled if seizures are well controlled on proper medication
• Patients of childbearing potential must have a negative pregnancy test to be eligible for this study and must agree to use adequate contraception while enrolled on this study.

Other inclusion and exclusion criteria may apply and will be reviewed by your treating team.

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Study Description

This is a phase I/II study that studies the drug SNDX-5613 in patients with acute leukemia. In phase 1, the dose will be increased to find the maximum tolerated dose of SNDX-5613 and the recommended dose for the next phase will be determined. In phase 2, patients will be given the recommended phase 2 dose determined in phase 1, and the safety and efficacy in patients with various tumour mutation will be studied. 

Inclusion Criteria

• Patients must have active acute leukemia with certain genetic characteristics
• Patients must be over 30 days old 
• Patients must be up and about more than 50% of waking hours (if applicable)
• Adequate time must have passed from all previous treatments (i.e at least 60 days must have passed from last radiation treatment/stem cell infusion (if applicable))
• Adeqaute organ function
• Blood work must come back within acceptable ranges
• Patients of child bearing potential must be willing to use a highly effective method of contraception from the time of enrollment to 120 days after the last study drug dose
• Patients and/or their families/caregivers must sign a consent form outlining all assessments and requirements

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Study Description

The purpose of this study is to see if the experimental drug DAY101 is safe and effective in treating recurrent or progressive (tumor that has come back or isn’t improving despite treatment) glioma or solid tumors in pediatric, adolescent and young adult patients. The drug will be given in the form of oral tablets.

Inclusion Criteria

• Age between 6 months to 25 years
• Patient must be diagnosed with low grade glioma or solid tumor, that isn’t improving despite treatment 
• The tumour must display a genetic change called a "RAF alteration"
• Patient must be able to swallow oral tablets
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team