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Diffuse Intrinsic Pontine Glioma clinical trials

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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.

NCT ID: NCT05278208 Recruiting - Medulloblastoma Clinical Trials

Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors

Start date: November 21, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4-12 years (Phase I) or older than 12 yrs (Phase II) to test its safety and efficacy, respectively. Funding Source - FDA OOPD (grant number FD-R-0532-01)

NCT ID: NCT05123534 Recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients With DIPG

Start date: August 12, 2022
Phase: Phase 2
Study type: Interventional

The primary objectives of this trial are to evaluate the safety and tolerability of sonodynamic therapy (SDT) using SONALA-001 and Exablate Type 2.0 device and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of MR-Guided Focused Ultrasound (MRgFUS) energy in combination with SONALA-001 in subjects with diffuse intrinsic pontine glioma Funding Source - FDA OOPD

NCT ID: NCT05099003 Suspended - Glioblastoma Clinical Trials

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

Start date: May 31, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic change called H3 K27M mutation. It also tests whether combination of selinexor and standard radiation therapy works to shrink tumors in this patient population. Glioma is a type of cancer that occurs in the brain or spine. Glioma is considered high risk (or high-grade) when it is growing and spreading quickly. The term, risk, refers to the chance of the cancer coming back after treatment. DIPG is a subtype of HGG that grows in the pons (a part of the brainstem that controls functions like breathing, swallowing, speaking, and eye movements). This trial has two parts. The only difference in treatment between the two parts is that some subjects treated in Part 1 may receive a different dose of selinexor than the subjects treated in Part 2. In Part 1 (also called the Dose-Finding Phase), investigators want to determine the dose of selinexor that can be given without causing side effects that are too severe. This dose is called the maximum tolerated dose (MTD). In Part 2 (also called the Efficacy Phase), investigators want to find out how effective the MTD of selinexor is against HGG or DIPG. Selinexor blocks a protein called CRM1, which may help keep cancer cells from growing and may kill them. It is a type of small molecule inhibitor called selective inhibitors of nuclear export (SINE). Radiation therapy uses high energy to kill tumor cells and shrink tumors. The combination of selinexor and radiation therapy may be effective in treating patients with newly-diagnosed DIPG and H3 K27M-Mutant HGG.