Canadian clinical trial registry

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Study Description

The purpose of this research study is to investigate an experimental drug, MK-3475 (also called pembrolizumab), in young patients. The drug MK-3475 has been previously studied in adults, in a variety of tumors, but is not yet FDA approved. The first phase is a safety study to assess side effects and best dose of pembrolizumab, the second phase is the efficacy portion to see how well it works in treating childhood brain tumors that have come back (recurrent), progressed, or not responded (refractory) to previous treatment. 

(transcribed from PBTC-045 Summary for Patients and Families)

Inclusion Criteria

• Patient must have one of the following diagnoses that have come back, progressed or not responded to treatment, to be eligible: 
  • Stratum A : DIPG - currently closed to enrollment
  • Stratum B : Non-brainstem high-grade glioma (NB-HGG)
  • Stratum C : Hypermutated brain tumor
  • Stratum D : Ependymoma
  • Stratum E : Medulloblastoma 
• Patient must have been treated with prior radiation therapy and/or chemotherapy (exclusions apply)
• Both males and females of all races and ethnic groups are eligible for this study
• Patient must be able to be up and about more than 50% of their waking hours
• Age Requirements:
  • Stratum A  -  1 year to 18 years old during safety portion, <22 years during efficacy, currently closed to enrollment
  • Stratum B  - 1 year to 18 years old during safety portion, <22 years during efficacy
  • Stratum C  - Younger than 30 years old
  • Stratum D  - 1 year to 18 years old during safety portion, <22 years during efficacy
  • Stratum E  - 1 year to 18 years old during safety portion, <22 years during efficacy
• Patients must have satisfactory blood work prior to enrolling
• Patient must not have any shortness of breath
• Human immunodeficiency virus (HIV)-infected patients with undetectable viral load within 6 months are eligible for this trial
• Patients of child bearing potential must NOT be pregnant, and must agree to use 2 methods of birth control, be surgically sterile, or abstain from heterosexual activity while on study and 6 months after
• Patient and/or guardian must sign a written consent document

Additional inclusion and exclusion criteria may apply.

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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

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Study Description

This trial is looking at whether adding a medicine called melphalan (which is injected into the eye) to regular chemotherapy can help treat children with retinoblastoma, a type of eye cancer. Retinoblastoma can sometimes be harder to treat when there are tiny bits of the tumor floating in the jelly-like part of the eye - called vitreous seeds. Melphalan, along with other chemotherapy drugs, works by stopping cancer cells from growing and dividing. The goal of this study is to see if adding melphalan early in treatment can better target those floating tumor bits and improve treatment for retinoblastoma.

Inclusion Criteria

• Must be under 18 years old
• The child must have a new diagnosis of retinoblastoma (a type of eye cancer) that is still in the eye 
• Participant must meet one of the following conditions: 
  • Retinoblastoma in one eye (Group D) with tumor pieces floating in the eye fluid.
  • Retinoblastoma in both eyes, with one eye in Group D (with tumor pieces in the fluid) and the other eye less severe (Group A-C).
  • Retinoblastoma in both eyes, with at least one eye in Group D (with tumor pieces in the fluid).
  • Retinoblastoma in both eyes, with one eye in Group D (with tumor pieces in the fluid) and the other eye in Group E (most severe), where the Group E eye was removed before any treatment.
  • Retinoblastoma in both eyes, with one eye in Group D (with tumor pieces in the fluid) and one Group E eye that hasn't been removed yet (depending on the doctor's decision).
• The child must be in good enough health to handle treatment, based on performance scores for their age.
• Blood counts and kidney function must meet certain safety levels before treatment.

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

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Study Description

This is a phase 1/2 study that studies the drug avapritinib in patients 2-17 years old with solid tumors that have come back (relapsed) or have not responded to previous treatment (refractory). The tumor must have a certain genetic mutation (in KIT, PDGFRA or H3K27M (glioma only)) to qualify you for the study. The study consists of 2 parts; in part 1, more information will be gathered about the drug's safety and how it moves through the body (pharmacokinetics or PK) and in part 2, the effectiveness, safety and PK will continued to be monitored at the recommended dose. 

Inclusion Criteria

• Patients must be between 2-17 years old
• Patients must have a diagnosed solid or central nervous system (CNS) tumor that has progressed despite prior standard therapy or no alternative treatment is available 
• Patients must be able to be up and about at least half of their waking hours (if applicable)
• Blood work must come back within acceptable ranges within 14 days of the first study dose
• Patients must not be pregnant on the trial, participants of child bearing potential must agree to use approved contraception methods
• Patients and/or their families/caregivers must sign a consent form outlining all assessments and requirements

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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

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 will evaluate the combination of two drugs called favezelimab and pembrolizumab to see how effective and safe it is for treating patients with a cancer called lymphoma. There are various different kinds of lymphoma, this study is for patients with classical Hodgkin, indolent non-Hodgkin or diffuse large B-cell lymphoma. 

Inclusion Criteria

• Participants must be 18 years of age or older 
• Participants must have a diagnosis of:
  • classical Hodgkin lymphoma (cHL)
  • diffuse large B-cell lymphoma (DLBCL)
  • indolent non-Hodgkin lymphoma (iNHL)
• Must have a tumour that can be measured on CT or MRI 
• Participant should be well enough to carry out light daily tasks, e.g., light house work, office work, normal activities

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

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Study Description

This is a Phase 1b/2 study of the drug DAY101 in patients ≥12 years of age with solid tumours or brain tumours that have come back or progressed. This study includes 2 sub-studies, patients in sub-study A will receive the DAY-101 drug and patients in sub-study B will receive "DAY-101" and another drug called pimasertib in combination.

Inclusion Criteria

• Participants must be between 12 to 18 years old
• Participants must have a solid tumour or brain tumour that has come back (relapsed) or progressed 
• Participants must have a qualifying gene change in the tumour (MAPK pathway)
• If enrolled on study, patients and their families must agree to the study requirements by signing an informed consent/assent form

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