Phase 2 Trial of G207 + 5 Gy Radiation for Children With High-Grade Gliomas

Inclusion Criteria: Exclusion Criteria: Pregnancy Pregnant women are excluded from this study. Female patients of childbearing potential must have a negative serum or urine pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Pregnant women are excluded from this study because G207 is an agent with the potential for teratogenic or abortifacient effects. Lactation Status Lactating females are not eligible unless they have agreed not to breastfeed their infants Because there is an unknown potential risk for adverse events in nursing infants secondary to treatment of the mother with G207, breastfeeding should be discontinued if the mother is treated with G207. Disease-Related Exclusion Criteria Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial. Patients with primary tumor involving the cerebellum, brainstem or spinal cord, or that would require surgical access through a ventricle to deliver the prescribed protocol treatment. Metastatic disease or diffuse, widespread, abnormal tumor pattern involving 3 or more lobes of the brain. Tumor with evidence of clinically significant uncal herniation or midline shift, or evidence of ventricular obstruction from tumor or tonsillar herniation. Concurrent Illness Patients with any clinically significant unrelated …