This trial will evaluate the activity of dasatinib in combination with everolimus for children with gliomas harboring PDGFR alterations, including newly diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) after radiation (stratum A); and recurrent/progressive glioma (grade II-IV, including DIPG) (stratum B).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
60 mg/m2 orally twice daily
3.0 mg/m2, with titration of dosing after first cycle to keep trough level of 5-15 ug/ml
University of Michigan Cancer Center
Ann Arbor, Michigan, United States
Progression-free Survival in Participants With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)
Percentage of participants without progression, defined as 25% increase in the size of the tumor or appearance of new lesions.
Time frame: 8 months
Progression-free Survival in Participants With Newly Diagnosed High-grade Glioma (HGG)
Percentage of participants without progression, defined as 25% increase in the size of the tumor or appearance of new lesions.
Time frame: 12 months
Overall Response Rate (OR) (Partial Response or Better) in Participants With Refractory or Recurrent Glioma
The overall response assessment will take into account response in both target and non-target lesions, as well as the appearance of new lesions. Partial Response (PR) will be defined as ≥50% decrease in size of tumor in comparison to baseline measurements. Complete Response (CR) will be defined as the disappearance of all abnormal signal. This includes return to normal size of the brain stem for brain stem lesions. Reported as percentage of participants with partial or better response at 56 days.
Time frame: 56 Days
Overall Survival
Percentage of patients alive at one year.
Time frame: 1 year
Overall Survival
Percentage of participants alive at 2 years.
Time frame: up to 17 months
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