Phase
Condition
Brain Cancer
Astrocytoma
Brain Tumor
Treatment
Positron Emission Tomography
Dasatinib
Temozolomide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years
Prior diagnosis of a glioma treated with chemotherapy and/or radiation with stabledisease based on Response Assessment in Neuro-Oncology (RANO) criteria
Must have IDH-mutant OR MGMT-methylated glioma
NOTE: Patients with any radiographic evidence of residual disease areeligible
Eastern Cooperative Oncology Group (ECOG) of 0, 1, or 2, and Karnofsky performancestatus >= 50
Hemoglobin ≥ 9.0 g/dL (≤ 15 days prior to registration)
Absolute neutrophil count (ANC) ≥ 1500/mm^3 (≤ 15 days prior to registration)
Platelet count ≥ 100,000/mm^3 (without transfusion ≤ 7 days preceding labassessment) (≤ 15 days prior to registration)
Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x upper limitof normal (ULN) (or ≤ 5 x ULN for patients with liver involvement) (≤ 15 days priorto registration)
Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula (≤ 15days prior to registration)
Average corrected QT interval (QTc) ≤ 450 ms on triplicate 12 lead electrocardiogram (ECG) ≤ 29 days prior to registration
NOTE: QTc intervals will be corrected using Fridericia's formula (Fridericia
Negative serum pregnancy test is required for persons of childbearing potential ≤ 8days prior to registration
Presence of an implanted cranial CSF access device, such as Ommaya reservoir orventriculoperitoneal shunt
Willingness to provide blood and CSF samples for research
Co-enrollment on the neuro-oncology biorepository [institutional review board (IRB) 12-003458] for collection of research blood and CSF samples
Provide written informed consent
Willingness to return to Mayo Clinic for follow-up
Exclusion
Exclusion Criteria:
Any of the following because this study involves an agent that has known genotoxic,mutagenic and teratogenic effects:
Pregnant persons
Nursing persons
Persons of childbearing potential and persons able to father a child who areunwilling to employ adequate contraception
Patients who are not appropriate medical candidates due to current or past medicalhistory or uncontrolled concurrent illness which limits safety of or compliance tostudy proceedings
Participants who are unable to swallow tablets or who are at risk for impairedabsorption of oral medication
NOTE: This includes but not limited to, refractory vomiting, gastricresection/bypass, or duodenal/jejunal resection
Patients with known hypersensitivity or allergy to all of the study drugs on theprotocol (known hypersensitivity or allergy to one drug does not precludeparticipation in this protocol)
Inability to undergo MRI scans
Study Design
Connect with a study center
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
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