Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab

Inclusion Criteria

• •1. Patients must have pathologically proven diagnosis of high grade (aka grade III or IV) glioma that has progressed on bevacizumab (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, gliosarcoma, H3K27M mutant glioma).
• •2. Patients must have received prior radiation therapy and standard temozolomide. Patients who have received any number of therapies for previous progressions will be considered eligible.
• •3. Patients must be three or more months from the end of chemoradiotherapy or have biopsy or imaging consistent with disease progression.
• •4. Physiologic Status/Age: Patients must be 19 years of age or older (the age of consent in Nebraska.)
• •5. Patients must have recovered from any toxicity of prior therapy to Grade 1 or less.
• •6. ECOG Performance Status of 0-3.
• •7. Patients must have an adequate bone marrow reserve (ANC count ≥1,500/mm3, hemoglobin \> 8 g/dL, platelet count ≥100,000/mm3).
• •8. Patients must have adequate renal and hepatic function with:
• •1. creatinine \< 1.5 x institutional upper limit of normal (ULN).
• •2. total bilirubin \< 1.5 x ULN (unless due to Gilbert's disease)
• •3. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \<2.5 x ULN
• •4. serum alkaline phosphatase less than 2.5 times the upper limits of normal)
• •9. The patient must willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
• •10. Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment.
• •11. Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study. (Non-child bearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries).