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Diffuse Intrinsic Pontine Glioma clinical trials

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NCT ID: NCT05839379 Not yet recruiting - Glioblastoma Clinical Trials

Targeted Pediatric High-Grade Glioma Therapy

Start date: June 28, 2024
Phase:
Study type: Observational

The goal of this study is to perform genetic sequencing on brain tumors from children, adolescents, and young adult patients who have been newly diagnosed with a high-grade glioma. This molecular profiling will decide if patients are eligible to participate in a subsequent treatment-based clinical trial based on the genetic alterations identified in their tumor.

NCT ID: NCT05768880 Recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

Study of B7-H3, EGFR806, HER2, And IL13-Zetakine (Quad) CAR T Cell Locoregional Immunotherapy For Pediatric Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, And Recurrent Or Refractory Central Nervous System Tumors

Start date: May 5, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with SC-CAR4BRAIN, an autologous CD4+ and CD8+ T cells lentivirally transduced to express to express combinations of B7-H3, EGFR806, HER2, and IL13-zetakine chimeric antigen receptors (CAR). CAR T cells are delivered via an indwelling catheter into the ventricular system in children and young adults with diffuse intrinsic pontine glioma (DIPG), diffuse midline glioma (DMG), and recurrent or refractory CNS tumors. A child or young adult meeting all eligibility criteria, including having a CNS catheter placed into their ventricular system, and meeting none of the exclusion criteria will have their T cells collected. The T cells will then be bioengineered into a second-generation CAR T cell that target B7H3, EGFR806, HER2, and IL13-zetakine on tumor cells. Patients will be assigned to 1 of 2 treatment Arms based on the type of their tumor: - Arm A is for patients with DIPG (meaning primary disease localized to the pons, metastatic disease is allowed) anytime after standard radiation OR after progression. - Arm B is for patients with non-pontine DMG (meaning DMG in other parts of the brain such as the thalamus or spine) anytime after standard radiation OR after progression. This Arm also includes other recurrent/refractory CNS tumors.

NCT ID: NCT05762419 Active, not recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

FUS Etoposide for DMG

Start date: June 5, 2023
Phase: Phase 1
Study type: Interventional

The blood brain barrier (BBB) prevents some drugs from successfully reaching the target tumor. Focused Ultrasound (FUS) using microbubbles and neuro-navigator controlled sonication is a non-invasive method of temporarily opening up the blood brain barrier to allow a greater concentration of the drug to reach into the brain tumor. This may improve response and may also reduce system side effects in the patient. The primary purpose of this study is to evaluate the feasibility of safely opening the blood brain barrier in children with progressive diffuse midline gliomas (DMG) treated with oral etoposide using focused ultrasound with microbubbles and neuro-navigator-controlled sonication. For the purpose of the study, the investigators will be opening up the blood brain barrier temporarily in one or two locations around the tumor using the non-invasive focused ultrasound technology, and administrating oral etoposide in children with progressive diffuse midline glioma.

NCT ID: NCT05717712 Recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

Oncolytic Virus Ad-TD-nsIL12 for Primary Pediatric Diffuse Intrinsic Pontine Glioma

Start date: January 4, 2023
Phase: Phase 1
Study type: Interventional

This is a drug safety assessment clinical trial with a 3+3 dose escalation design, to observe the safety, tolerability and toxicity of a novel oncolytic virus Ad-TD-nsIL12 intratumoral injection in primary DIPG patients (NCI-CTCAE V5.0).

NCT ID: NCT05717699 Recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma

Start date: January 4, 2023
Phase: Phase 1
Study type: Interventional

This is a single-arm, single-center, drug safety assessment clinical trial with a 3+3 dose escalation design, to observe the safety, tolerability and toxicity of a novel oncolytic virus Ad-TD-nsIL12 intratumoral injection in progressive DIPG patients (NCI-CTCAE V5.0).

NCT ID: NCT05518838 Available - Clinical trials for Diffuse Intrinsic Pontine Glioma

Expanded Access to OKN-007 for Patients With Diffuse Midline Glioma, H3 K27-altered

Start date: n/a
Phase:
Study type: Expanded Access

To provide OKN-007 for compassionate use in patients with diffuse midline glioma, H3 K27-altered (DMG), including diffuse intrinsic pontine glioma (DIPG), pediatric and young adult patients with high-grade diffuse midline glioma will be treated under this Intermediate-sized expanded access treatment protocol.

NCT ID: NCT05500508 Recruiting - Breast Cancer Clinical Trials

Oral AMXT 1501 Dicaprate in Combination With IV DFMO

Start date: November 29, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1B/2A study will be conducted to establish safety and dose level of AMXT 1501 dicaprate in combination with IV DFMO, in cancer patients.

NCT ID: NCT05476939 Recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0

BIOMEDE 2
Start date: September 29, 2022
Phase: Phase 3
Study type: Interventional

The BIOMEDE 2.0 study is the second stage of the BIOMEDE multi-arm, multistage rolling programme (adaptive platform protocol). It is a multicenter, randomized, open-label, controlled phase-3 trial evaluating efficacy of ONC201 in comparison with everolimus (primary objective based on internal comparison) and subsequently to historical controls. Two treatment groups will be compared. A switch between treatment groups is allowed after confirmation of the disease progression (real-time central review blinded to the treatment arm allocation). Study treatment will be continued until centrally confirmed disease progression (either radiologically or histologically), unacceptable toxicity or consent withdrawal. The final conclusion of the trial will be successful for ONC201, if ONC201 is found significantly superior to everolimus in terms of centrally-reviewed PFS (Progression-free survival) from randomization (internal comparison) either overall, considering ND-DMG and DIPG-patients together, or in the subgroup of ND-DMG patients alone. In other cases, Everolimus will remain the standard arm unless it appears associated with an excess of toxicity compared to ONC201 which could then be discussed as a new standard.

NCT ID: NCT05392374 No longer available - Glioma Clinical Trials

Expanded Access Use of ONC201 in a Patient With Diffuse Intrinsic Pontine Gliomas

Start date: n/a
Phase:
Study type: Expanded Access

This is an intermediate-size expanded access protocol to provide ONC201 to patients with diffuse intrinsic pontine gliomas who cannot access ONC201 through clinical trials.

NCT ID: NCT05298995 Recruiting - High Grade Glioma Clinical Trials

GD2-CAR T Cells for Pediatric Brain Tumours

Start date: November 9, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety and efficacy of iC9-GD2-CAR T-cells, a third generation (4.1BB-CD28) CAR T cell treatment targeting GD2 in paediatric or young adult patients affected by relapsed/refractory malignant central nervous system (CNS) tumors. In order to improve the safety of the approach, the suicide gene inducible Caspase 9 (iC9) has been included.