Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)

Study on Investigational Medications for Glioma with BRAF V600 Mutation

Recruiting
1 years - 17 years
All
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma or relapsed or refractory high grade glioma.

Detailed description of study

The purpose of this clinical research study is to find out if the drugs dabrafenib and trametinib are safe and beneficial in people with BRAF mutation positive LGG or relapsed or refractory BRAF mutation positive HGG.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Zanthiastrocytoma,Rosette-forming Glioneurona Tumor,Glioma,Astrocytoma,Iponeurocytoma,Gangliocytoma,High Grade Glioma,Glioblastoma,BRAF mutation,Papillary Glioneuronal Tumor,Oligodenroglioma,Low Grade Glioma,Neurocytoma
  • Age: 1 years - 17 years
  • Gender: All

Inclusion Criteria


Diagnosis of BRAF V600 mutant High Grade glioma that has relapsed, progressed or failed to respond to frontline therapy

Diagnosis of BRAF V600 mutant Low Grade glioma with progressive disease following surgical excision, or non-surgical candidates with necessity to begin first systemic treatment because of a risk of neurological impairment with progression.

Confirmed measurable disease

Exclusion Criteria

Previous treatment with dabrafenib, trametinib, other RAF inhibitor, other MEK or ERK inhibitor

HGG patient: Cancer treatment within the past 3 weeks.

LGG patient: Any systemic therapy or radiotherapy prior to enrollment

LGG patients: history of allergic reaction or contraindications to the use of carboplatin or vincristine

Stem cell transplant within the past 3 months

History of heart disease

Pregnant or lactating females

Updated on 19 Feb 2024. Study ID: 1803872717 (PHO-FERG-NOVARTIS-36G2201)

This study investigates the use of investigational medications in children and adolescents with a specific type of brain tumor called glioma. Glioma is a type of tumor that occurs in the brain and spinal cord. The study focuses on patients who have a BRAF V600 mutation, which is a change in the gene that can affect cell growth. The study is looking at two types of glioma: low grade glioma (LGG) and high grade glioma (HGG) that has come back or is not responding to treatment.

Participants in the study will receive either the investigational medications or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will assess the safety and effects of these treatments on the tumors.

  • Who can participate: Children and adolescents with glioma and a BRAF V600 mutation can participate. They must have relapsed or unresponsive tumors or progressive disease, without prior similar treatments or recent cancer therapies.
  • Study details: Participants will receive either the investigational medications or a placebo. The study will monitor the safety and effects of these treatments on the tumors.

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