Phase I Study of Mebendazole Therapy for Recurrent/Progressive Pediatric Brain Tumors

Inclusion criteria

• ✓. Patients must have a confirmed recurrent/progressive brain malignancy that have failed at least one prior treatment regimen.
• ✓. Age for inclusion in this trial at time of patient enrollment is ≥ 1 year, and up to 21 years (prior to the 22nd birthday) with any of the recurrent medulloblastoma or recurrent high grade glioma may be consented and treated under this protocol. Patients who turn 22 during the course of the trial will continue to be treated.
• ✓. Karnofsky Performance Score (KPS) \> 50% for patients ≥10 years of age. Lansky score of ≥ 50 for children \< 10 years of age.
• ✓. Life expectancy greater than 10 weeks.
• ✓. Patients must have adequate organ and marrow function as defined below:
• ✓. The effects of mebendazole on the developing human fetus are unknown. In rats there is evidence of a teratogenic effect, although there is no evidence of adverse effect from women accidently taking mebendazole (at lower doses) during pregnancy. For this reason, women of child-bearing potential should agree to use birth control while taking mebendazole if there is a reasonable risk of pregnancy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• ✓. Ability for patient (and if applicable parent or legal guardian) understand and the willingness to sign a written informed consent document, or for a parent or legal guardian to give assent for those cases where a very young patient is unable to understand or sign the consent.