INCB7839 dosing will begin at 120 mg/m2/dose BID which is equivalent to the adult RP2D (200 mg PO BID) based on a typical adult size of 1.67m2. The INCB7839 dose may be decreased to 80 mg/m2/dose BID if the staring dose is not tolerable. 28 consecutive days (4 weeks) will constitute one course. Patients may continue to receive INCB7839 for 26 courses (approximately 2 years).

Glioblastoma Multiforme

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

DIPG

High-grade Astrocytoma NOS

CNS Primary Tumor, NOS (Malignant Glioma)

INCB7839

Children's Hospital Los Angeles

Lucile Packard Children Hospital Stanford University

Children's Hospital Colorado

Children's National Medical Center

Children's Healthcare of Atlanta

Lurie Childrens Hospital-Chicago

National Cancer Institute Pediatric Oncology Branch

Dana Farber Cancer Institute

Memorial Sloan Kettering Cancer Center

Cincinnati Children Hospital Medical Center

Children Hospital of Pittsburgh of UPMC

St. Jude Children Research Hospital

Baylor College of Medicine

INCB7839 in Treating Children With Recurrent/Progressive High-Grade Gliomas

A Phase I Study of the Adam-10 Inhibitor, INCB7839 in Children With Recurrent/Progressive High-Grade Gliomas to Target Microenvironmental Neuroligin-3

Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0.

To estimate the maximum tolerated dose (MTD) and/or recommend Phase II dose (RP2D) of INCB7839 administered orally in children with recurrent/progressive high-grade glioma.

The area under the curve (AUC) will be calculated based on the course 1 days 1 and 2 pharmacokinetic samples.

The maximum concentration [CMAX] will be calculated based on the course 1 days 1 and 2 pharmacokinetic samples.

The apparent oral clearance [CL/F] will be calculated based on the course 1 days 1 and 2 pharmacokinetic samples.

The time to reach CMAX [TMAX] will be calculated based on the course 1 days 1 and 2 pharmacokinetic samples.

The progression-free survival will be reported.

The duration of response will be reported.

HER2 extracellular domain in serum will be reported.

Neuroligin-3 (NLGN3) in cerebral spinal fluid will be reported.

The maximum concentration [CMAX] will be calculated based on the CSF pharmacokinetic samples.

Pediatric Brain Tumor Consortium

This is a phase I study and we will use a design similar to the Rolling-6 design and open 6 slots initially on Dose level 1. If we observe no-more than 1 DLT in these 6 subjects then we would expand this cohort to at least 12 patients for PK and additional safety information. If more than 1 DLT is observed on dose level 1 in 2-6 subjects, then further enrollment to dose level 1 will stop, the dose will be de-escalated to dose level 0 and the same approach will be repeated. Based on the above-outlined de-escalation rules, if dose level 0 is found to be too toxic, then the trial will be closed to accrual and the merits of amending or closing the trial permanently will be reconsidered.

Participate in an in-person session followed by a series of at-home assignments, and two booster sessions

Participants will briefly meet with a member of the research team who will assess parent and child coping, and provide the child- caregiver dyad educational material about coping with cancer

Glioblastomas

Sarcoma

Astrocytoma

Brain Cancer

Leukemia

The 8-week EMI will consist of one initial in-person session with the child and parent, a series of at- home assignments, and two "booster" sessions. The psychoeducation group will be given educational material about coping with cancer.

Enhanced Mindfulness Intervention

The psychoeducation group will be offered the opportunity to participate in the EMI 8 weeks post-baseline

Psychoeducation

National Institutes of Health Clinical Center

Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers

Feasibility and Preliminary Efficacy of an Enhanced Mindfulness- Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers: A Pilot Randomized Controlled Trial

Descriptive and summary statistics will be used to report parent and child ratings of intervention completion, as well as satisfaction with the intervention via responses on a feasibility questionnaire

National Cancer Institute (NCI)

treatment of diffuse pontine glioma with MDV9300 with the combination of radiation and low dose cyclophosphamide

The study will be done in the following manner:
Evaluation of MDV9300 and radiation-
Cohort A-3 patients: first dose of MDV9300 3mg/m2 .If no toxicity over grade 2-second dose and on -6 mg/kg.
Cohort B -3 patiens: if no toxicity >grade 2 seen in cohort A- start dose will be 6 mg/kg If toxicity> grade 2 in 2 patients or more on a dose of 3 mg/kg the dose in cohort B will be 1 mg/kg during irradiation If toxicity> grade 2 in 2 patients or more on a dose of 1 mg/kg no further concurrent MDV9300 and radiation will be given
Evaluation of MDV9300 and cyclophosphamide
After completion of the first phase (6 patients) a cohort of 15 patients will be accrued. The treatment protocol of this cohort will be as follows:
Following radiation completion , and after recovery from treatment adverse events of grade 2 and higher, the patients will be started on concurrent biweekly MDV9300 and weekly cyclophosphamide 200mg/m2

MDV9300

Hadassah Hebrew University Hospital

Anti PD1 Antibody in Diffuse Intrinsic Pontine Glioma

A Phase I/ II Clinical Trial of MDV9300 (Pidilizumab) in Diffuse Intrinsic Pontine Glioma

Treatment related toxicity according to NCI CTC Version 4.0 will be recorded throughout treatment. a patient with grade 3 or more treatment related toxicity will receive 50% dose reduction. if again grade 3 treatment related toxicity will occur the patient will be taken off study.

diffuse intrinsic pontine glioma/väsymys

INCB7839 in Treating Children With Recurrent/Progressive High-Grade Gliomas

Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers

Anti PD1 Antibody in Diffuse Intrinsic Pontine Glioma

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