Brain Tumor Clinical Trials

ClinicalTrials.gov Identifier: NCT05233397

Description:

• In this Phase II, tociluzumab will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy.

Key Eligibility Criteria: 

• Stratum 1: Patients ≥ 12 months and ≤ 39 years of age with recurrent or progressive adamantinomatous craniopharyngioma at least 6 months post completion of radiation therapy
• Stratum 2: Patients ≥ 12 months and ≤ 39 years of age with recurrent or progressive adamantinomatous craniopharyngioma who have undergone surgery but have NOT previously undergone irradiation
• Progressive disease is allowed but not required

Sponsor:

• Nationwide Children's Hospital

Investigator:

• Eugene Hwang, MD

ClinicalTrials.gov Identifier: NCT05286788

Description

• Adamantinomatous Craniopharyngioma (ACP) is a highly debilitating pediatric brain tumor that lacks medical anti-tumor therapies. Current therapy, which depends largely on surgery and radiation, is associated with poor quality of life and becomes more challenging and risky in the setting of recurrent disease. MEKTOVI (binimetinib) is an oral, highly selective reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 that is being evaluated in pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma (ACP), including patients who have undergone surgery and/or radiation therapy.

Key Eligibility Criteria

• Patients aged >1 year and <25 years and must have progressive or recurrent ACP and have recovered or stabilized from the acute toxic effects of prior treatments
• Progressive disease is allowed but not required

Sponsor

• Nationwide Children’s Hospital

Investigator

• Eugene I. Hwang, MD

Disease Type

• Recurrent Adamantinomatous Craniopharyngioma (ACP)

ClinicalTrials.gov Identifier: NCT05233397

Description:

• In this Phase II, tociluzumab will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy.

Key Eligibility Criteria: 

• Stratum 1: Patients ≥ 12 months and ≤ 39 years of age with recurrent or progressive adamantinomatous craniopharyngioma at least 6 months post completion of radiation therapy
• Stratum 2: Patients ≥ 12 months and ≤ 39 years of age with recurrent or progressive adamantinomatous craniopharyngioma who have undergone surgery but have NOT previously undergone irradiation
• Progressive disease is allowed but not required

Sponsor:

• Nationwide Children's Hospital

Investigator:

• Eugene Hwang, MD

ClinicalTrials.gov Identifier: NCT05286788

Description

• Adamantinomatous Craniopharyngioma (ACP) is a highly debilitating pediatric brain tumor that lacks medical anti-tumor therapies. Current therapy, which depends largely on surgery and radiation, is associated with poor quality of life and becomes more challenging and risky in the setting of recurrent disease. MEKTOVI (binimetinib) is an oral, highly selective reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 that is being evaluated in pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma (ACP), including patients who have undergone surgery and/or radiation therapy.

Key Eligibility Criteria

• Patients aged >1 year and <25 years and must have progressive or recurrent ACP and have recovered or stabilized from the acute toxic effects of prior treatments
• Progressive disease is allowed but not required

Sponsor

• Nationwide Children’s Hospital

Investigator

• Eugene I. Hwang, MD

Disease Type

• Recurrent Adamantinomatous Craniopharyngioma (ACP)

ClinicalTrials.gov Identifier: NCT04655404

Description:

• This study will evaluate disease status in children that have been newly diagnosed with high-grade glioma with NTRK fusion after 2 cycles of the medication (Larotrectinib) have been given. The study will also evaluate the safety of larotrectinib when given with chemotherapy or post-focal radiation therapy.

Key Eligibility Criteria: 

• Patients ≤ 21 years of age with newly diagnosed high grade glioma with NTRK fusion 

Sponsor:

• Nationwide Children's Hospital

Investigator: 

• Lindsay Kilburn, MD

ClinicalTrials.gov Identifier: NCT05839379

Official title:

• Targeted Pediatric High-Grade Glioma Therapy

Description:

• 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.

Key Eligibility Criteria:

• Patients ≥12 months and ≤39 years with newly diagnosed high-grade glioma (HGG), including diffuse intrinsic pontine glioma (DIPG) who have had a biopsy

Sponsor:

• Nationwide Children's Hospital

Investigator:

• Eugene Hwang, MD 

*For patients with PI3K/mTOR alterations

ClinicalTrials.gov ID: NCT05843253

Description:

• The goal of this study is to determine the efficacy of the study drugs ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target.

Key Eligibility Criteria:

• For patients with PI3K/mTOR alterations

Sponsor:

• Nationwide Children's Hospital

Investigator:

• Eugene Hwang, MD

ClinicalTrials.gov Identifier: NCT06413706

Description:

• The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. 

Key Eligibility Criteria:

• Patients less than 21 years of age with biopsy proven high grade glioma

Sponsor:

• Eli Lilly and Company

Investigator:

• Lindsay Kilburn, MD

ClinicalTrials.gov Identifier: NCT04573140

Description:

• The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or unmethylated in adults only) and (Stratum 2) in pediatric patients with newly diagnosed HGG (pHGG).

Key Eligibility Criteria:

• Patients age > 3 and < 25 years with newly diagnosed high grade glioma, prior to surgical resection and radiation

Sponsor:

• University of Florida

Investigator:

• Lindsay Kilburn, MD

ClinicalTrials.gov Identifier: NCT05096481

Description:

• This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB).

Key Eligibility Criteria:

• Patients aged ≥3 and ≤39 years with recurrent/progressive medulloblastoma, newly diagnosed high grade glioma, or newly diagnosed diffuse intrinsic pontine glioma (biopsy not required)

Sponsor:

• Nationwide Children's Hospital

Investigator:

• Eugene Hwang, MD

*For patients with BRAF or NF-1 alterations

ClinicalTrials.gov Identifier: NCT06712875

Description:

• This is a pilot study evaluating the toxicity and early efficacy of dabrafenib and/or trametinib combined with nivolumab for the treatment of BRAF-altered or NF altered gliomas. 

Key Eligibility Criteria: 

• Cohort A: Patients ≥1 and ≤26 years of age with a recurrent or progressive low grade glioma harboring a KIAA1549-BRAF fusion, or a newly diagnosed high grade glioma harboring a KIAA1549-BRAF fusion

• Cohort B: Patients ≥1 and ≤26 years of age with NF-1 associated or altered low-grade glioma that is recurrent or progressive, high-grade glioma that is newly diagnosed or recurrent, or transforming glioma that is newly diagnosed or recurrent

Sponsor:

• Ann & Robert H Lurie Children's Hospital of Chicago 

Investigator:

• Lindsay Kilburn, MD