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This is an intermediate-size expanded access protocol to provide ONC201 to patients with diffuse intrinsic pontine gliomas who cannot access ONC201 through clinical trials.
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Inclusion criteria
Patient with DIPG who failed at least one line of prior therapy such as focal radiation therapy
Patient must be > than 6 months and < 18 years of age.
Confirmed evidence of disease progression from immediately prior therapy or refractory to the immediately prior treatment.
Karnofsky/Lansky performance status ≥ 50.
Adequate organ and marrow function as defined below:
Absolute neutrophil count ≥1,000/mm3 without growth factor use ≤ 7 days prior to treatment (cycle 1 day 1, C1D1)
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Hemoglobin>8.0 mg/dL without red blood cell transfusion ≤ 3 days prior to C1D1
Total serum bilirubin<1.5 X upper limit of normal (ULN)
AST (SGOT)/ALT (SGPT)≤2 X ULN;; ≤ 5 X ULN if there is liver involvement secondary to tumor
Serum creatinine≤ 1.5 X ULN (OR creatinine clearance ≥ 60 mL/min/1.73 m2)
Ability to understand and the willingness to sign a written informed consent document by the patient or their legal guardian.
If patient is of child--bearing age, female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator or a designated associate.
Patient must be able to swallow capsules and retain orally administered medication.
Exclusion criteria
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Data sourced from clinicaltrials.gov
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