Phase II Pediatric Study With Dabrafenib in Combination With Trametinib in Patients With HGG and LGG
Trial Status: Active
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.
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
California
Orange
Children's Hospital of Orange County
Status: ACTIVE
Colorado
Aurora
Children's Hospital Colorado
Status: ACTIVE
Illinois
Chicago
Lurie Children's Hospital-Chicago
Status: ACTIVE
Indiana
Indianapolis
Riley Hospital for Children
Status: ACTIVE
Contact: Anne Bubnick
Phone: 317-948-0101
Email:
abubnick@iu.edu
Maryland
Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Lianne Greenspan
Phone: 617-632-3352
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE
New York
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Tennessee
Memphis
Saint Jude Children's Research Hospital
Status: CLOSED_TO_ACCRUAL
Texas
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479
Houston
Texas Children's Hospital
Status: ACTIVE
Trial Phase Phase II
Trial Type Treatment
Lead Organization
Novartis Pharmaceuticals Corporation
- Primary ID CDRB436G2201
- Secondary IDs NCI-2018-00387, 2015-004015-20
- Clinicaltrials.gov ID NCT02684058