Study of the Combination of Crizotinib and Dasatinib in Pediatric Research Participants With Diffuse Pontine Glioma (DIPG) and High-Grade Glioma (HGG)

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 27, 2012

Primary Completion Date

March 7, 2018

Study Completion Date

September 28, 2018

Conditions
Diffuse Intrinsic Pontine GliomaHigh-grade Glioma
Interventions
DRUG

Crizotinib

"Starting dose level:~* Initial Treatment Plan: 130 mg/m\^2 per dose~* Modified Treatment Plan per Amendment 1.0: 165 mg/m\^2 per dose~The dose of a single agent will be increased by approximately 30% in each subsequent cohort until the MTD of this combination is reached.~The doses of each agent will not exceed their single-agent MTD already determined for children with recurrent solid tumors.~Cycle 1 (28 days): once a day for 28 days~Cycles 2-26 (28 days each): once a day"

DRUG

Dasatinib

"Starting dose level: 50 mg/m\^2 per dose~The dose of a single agent will be increased by approximately 30% in each subsequent cohort until the MTD of this combination is reached.~The doses of each agent will not exceed their single-agent MTD already determined for children with recurrent solid tumors.~Cycle 1 (28 days): starting on day 3, once a day for 28 days~Cycles 2-26 (28 days each): once a day"

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER

NCT01644773 - Study of the Combination of Crizotinib and Dasatinib in Pediatric Research Participants With Diffuse Pontine Glioma (DIPG) and High-Grade Glioma (HGG) | Biotech Hunter | Biotech Hunter