Canadian clinical trial registry

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Study Description

Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and some patients who relapse following CD19 directed therapy relapse with CD19 negative leukemia. For this reason, the investigators are attempting to use T-cells obtained directly from the patient, which can be genetically modified to express two chimeric antigen receptors (CARs). One is to recognize CD19 and the other is to recognize CD22, both of which are proteins expressed on the surface of the leukemic cell in patients with CD19+CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through recognition of CD19 and CD22. This is a phase 1 study designed to determine the safety of the CAR+ T-cells and the feasibility of making enough to treat patients with CD19+CD22+ leukemia.

Inclusion Criteria

• First 2 subjects: male and female subjects age ≥18 and < 27 years (as of 2/16/18 the first 2 subjects were enrolled and treated); subsequent subjects: male and female subjects age ≥12 months of age and <27 years.
• Diagnosis of CD19+22+ leukemia relapsed or refractory
• Asymptomatic from CNS involvement
• Free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks prior to enrollment
• Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy
• No prior genetically modified cell therapy that is still detectable or virotherapy
• Willing to participate in long-term follow-up for up to 15 years, if enrolled in the study and receive T cell infusion

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 test the safety of a drug called lurbinectedin in solid tumours that have come back (relapsed) or not responded to treatment (refractory). It is conducted in 2 parts, Phase 2 will further assess this drug in participants with Ewing sarcoma specifically.

Inclusion Criteria

• Participant must meet the following age requirements:
  • Phase 1 Part 1: participants must be ≥ 2 to < 18 years of age.
  • Phase 1 Part 2: participants must be ≥ 2 to ≤ 30 years of age.
  • Phase 2: participants must be ≥ 2 to ≤ 30 years of age.
• Participant has a confirmed solid tumor (For phase 2, Ewing Sarcoma)
• The participant is up and about for more than half their waking hours
• Participant meets all lab value requirements during the screening period
• Participant weighs at least 15kg
• Must not be pregnant (if applicable), and/or must be on an acceptable birth control method 
• Must sign informed consent and agree to attending all required study assessments 

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

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Study Description

(from https://forpatients.roche.com/en/trials/cancer/solid-tumors/tumor-agnostic-precision-immuno-oncology-and-somatic-ta-50851.html)

This clinical trial is recruiting people who have advanced solid tumors that cannot be surgically removed. You (or your child) must have had genetic testing on the solid tumors that shows a positive result for one of the genetic changes, also known as biomarkers, being tested in this trial.

The purpose of this clinical trial is to compare the effects, good or bad, of different targeted therapies and immunotherapies in patients with solid tumors that cannot be surgically removed and show specific biomarkers.

To be able to take part in this clinical trial, you (or your child) must have been diagnosed with solid tumors that cannot be surgically removed and show one of the specific biomarkers that are being tested in this study:

• ROS1 fusion-positive tumors
• NTRK1/2/3 fusion-positive tumors
• TMB-high tumors
• ALK fusion-positive
• AKT1/2/3 mutant-positive tumors
• HER2 mutant-positive tumors
• PIK3CA multiple mutant-positive tumors
• BRAF class II mutant or fusion-positive tumors
• BRAF class III mutant-positive tumors
• RET fusion-positive tumors

Your doctor will be able to give you more information on the type of biomarker your solid tumors show. You must be otherwise in good health to take part. You will not be able to take part if you are pregnant or breastfeeding, or if you have received any recent treatment for your cancer. Some of the groups may have other specific requirements. Your doctor will be able to give you more information on this.

Inclusion Criteria

• Less than 18 years of age for cohort E and K
• Age between 12 and 17 years for cohorts E, F and H
• Diagnosis of advanced cancer that has spread to a different part of the body (metastasized) and can’t be removed by an operation (unresectable)
• Participants must be up and about at least 50% of their waking hours
• The cancer must have a specific genetic change in one of the following genes: ROS1, NTRK1/2/3, AKT, PIK3CA, HER2, BRAF, RET, or be TMB-high

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 evaluate the safety and efficacy of combining Focused Ultrasound (Exablate Model 4000 Type 2.0/2.1) with Doxorubicin therapy for the treatment of DIPG in pediatric patients.

Inclusion Criteria

• Age between 5 and 18 years, inclusive
• Patient diagnosed with DIPG
• Must be between 4-12 weeks from completion of radiation therapy
• Able to attend all study visits
• Able and willing to give consent and/or assent or have a legal guardian who is able and willing to do so
• If brain surgery occurred, at least 14 days passed since last brain surgery and the patient is fully recovered and neurologically stable

Additional inclusion and exclusion criteria may be discussed with you by the study team.

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Study Description

Some neuroblastoma have a specific genetic change or mutation called an ALK aberration.  ALK, or anaplastic lymphoma kinase, has been found in several adult and pediatric cancers.  ALK aberrations are present in about 14% of newly diagnosed patients with high-risk neuroblastoma, and can be found more frequently at the time of relapse.  Lorlatinib is a drug called an ALK inhibitor. It is expected to slow or stop the growth of cancer cells which have the ALK aberration. The aim of this phase I/II study is to evaluate the dose, safety, and tolerability of lorlatinib, including the effect it has on the cancer.  Lorlatinib will be given alone or in combination with chemotherapy in children with refractory, relapsed or progressive neuroblastoma with ALK alterations.

Inclusion Criteria

• Patients must have a diagnosis of neuroblastoma either by histologic verification (looking at a sample of the tumour under a microscope) of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines (HVA/VMA).
• Patients are required to have an activating ALK aberration in their tumor, which is identified through genetic testing.
• Patients must have high risk neuroblastoma. Patients who were initially considered low or intermediate risk, but then reclassified as high risk are also eligible.
• Patients must have at least ONE of the following: 1) Recurrent/progressive disease at any time prior to study enrollment, 2) Refractory disease, 3) Persistent disease

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

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Study Description

This phase I/II trial tests the safety, best dose, and whether elimusertib works in treating patients with solid tumors that have come back (relapsed) or does not respond to treatment (refractory). Elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Inclusion Criteria

• Age Restrictions: 
  • Part A:
    • Patients between >= 12 months and < 18 years of age
  • Part B:
    • Patients between >= 12 months and =< 30 years of age for the phase 2 expansion cohorts for both EWS and PAX3-FOXO1 ARMS.
    • Patients between >= 12 months and =< 21 years of age for the phase 2 DDR expansion cohort
• Patients must be able to swallow tablets of the study drug (elimusertib)
• Patients must have a solid tumor diagnosis that has come back (relapsed) or has not respond to treatment (refractory)
  • NOTE: further restrictions may apply for each cohort and will be discussed with you by the clinical team
• Patients must have measurable disease
• Patients must be up and about at least half of their waking hours
• Bloodwork requirements must be met prior to treatment
• Patients must meet the minimum duration from any prior anti-cancer therapy before enrolling. These timelines will be discussed with you by the clinical team.  
• Patients or their substitute decision maker must sign a consent form and agree to the required study assessments

Additional inclusion and exclusion crieria may apply 

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Study Description

This is a study of pembrolizumab (antibody against a marker called PD1) in children and adolescents who have any of the following types of cancer:

• advanced melanoma (now only open for patients age 12-18)
• advanced, relapsed or refractory cancer (except brain tumours and leukemia) that have this PD1 marker (now closed) 
• relapsed or refractory classical Hodgkin lymphoma 
• advanced relapsed or refractory cancer (except brain tumours and leukemia) that is known to be "microsatellite-instability-high (MSI-H)"
• advanced relapsed or refractory cancer (except brain tumours and leukemia) that is known to be "tumor-mutational burden-high" (TMB-H)"

Pembrolizumab 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, pembrolizumab 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.

This study has two parts. Part 1 will find the recommended dose for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy of pembrolizumab therapy.

Inclusion Criteria

• Age between 6 months and <18 years  (or between 3 years and <18 years of age for participants with Hodgkin's lymphoma) 
• Locally-advanced, or metastatic cancer (except brain tumours and leukemia) that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate. The cancer type has to meet one of the following types described in the "study description" section.
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

Publications

Geoerger B, Kang HJ, Yalon-Oren M, Marshall LV, Vezina C, Pappo A, Laetsch TW, Petrilli AS, Ebinger M, Toporski J, Glade-Bender J, Nicholls W, Fox E, DuBois SG, Macy ME, Cohn SL, Pathiraja K, Diede SJ, Ebbinghaus S, Pinto N. Pembrolizumab in paediatric patients with advanced melanoma or a PD-L1-positive, advanced, relapsed, or refractory solid tumour or lymphoma (KEYNOTE-051): interim analysis of an open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2020 Jan;21(1):121-133. doi: 10.1016/S1470-2045(19)30671-0. Epub 2019 Dec 4.

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Study Description

Diffuse Intrinsic Pontine Glioma (DIPG) is an aggressive brain tumour with no effective treatment and no chance of long-term survival . When this brain tumour grows back after the initial radiation therapy, it is known as progressive or recurrent DIPG.

This study will investigate how long a second treatment with radiation (re-irradiation) keeps progressive or recurrent DIPG from growing again and the overall survival of these patients. All children enrolled will be treated with re-irradiation.

Inclusion Criteria

• The patient is 17 years of age or younger at the time of first or second relapse or progression of disease
• The patient has no evidence of metastases on MRI of the brain and the spine
• The patient has received radiation in the past, given to a total dose of <60 Gy
• At least 180 days (6 months) have elapsed from the last day of primary radiation
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team