Canadian clinical trial registry

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Study Description

The purpose of this study is to determine the best dose, benefits and/or side effects of 2 drugs (magrolimab and dinutuximab) when given in combination to treat neuroblastoma that has come back (relapsed) or does not respond to treatment (refractory), or osteosarcoma that has come back (relapsed). These drugs (magrolimab and dinutuximab) interfere with the ability of cancer cells to grow and spread, using them in treatment may stop or shrink cancer growth in cases of neuroblastoma and osteosarcoma.

An additional aim of this study is determining the safety of these drugs (magrolimab and dinutuximab) when given after surgery to remove tumors from the lungs.

Inclusion Criteria

• Age between 1 and 35 years
• Patients must have:
  • neuroblastoma that has come back (relapsed) or does not respond to treatment (refractory) or
  • osteosarcoma that has come back (relapsed)
• 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

This study will test bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat, which may provide information about the patient's leukemia that is important when deciding how to best treat it and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.

Inclusion Criteria

• Patient must be less than 22 years old
• Patient must have a leukemia that has come back or not responded to other treatment
• Patient and/or their family must sign a written informed consent and agree to the study requirements 

Other inclusion and exclusion criteria may apply and will be discussed with you by the study 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

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 is study of a new medication called isatuximab (antibody against a marker called CD38) in combination with standard chemotherapy for children with acute lymphoblastic leukemia or acute myeloid leukemia that has relapsed or is refractory to treatment. The main objective of this study is to understand the anti-leukemia effect of this medication. 

Inclusion Criteria

• Age between 28 days to less than 18 years of age
• Acute lymphoblastic leukemia or acute myeloid leukemia that has 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 study is trying to determine the benefit of adding bevacizumab (an intravenous drug) to chemotherapy treatment with vinblastine, in children and adolescents with low grade gliomas.

Participants in this trial will be randomised (randomly assigned) into one of two treatment arms.

• Arm A will include 68 weeks (16 months) of single agent Vinblastine given once weekly intravenously.
• Arm B will include 68 weeks (16 months) of Vinblastine given weekly intravenously with the addition of 12 doses of bevacizumab given every two weeks intravenously for the initial 24 weeks (6 months).

Inclusion Criteria

• Children and adolescents aged 6 months to < 18 years
• Low grade glioma 
• The tumour must have grown back after surgery with clear imaging or clinical signs, or
• The tumour was partially removed with surgery and there is a necessity to begin treatment because of a risk of neurological impairment with progression.
• 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 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.