ACNS0927: A Phase 1/2 Study of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) and Local Irradiation, Followed by Maintenance SAHA in Children with Newly Diagnosed Diffuse Intrinsic Pontine Gliomas (DIPG)

Service: Trial Number:
074-12
Principal Investigator: Conducted at:
Miller Children's & Women's Hospital Long Beach
Currently enrolling additional patients:
Yes

Diffuse Intrinsic Pontine Gliomas (DIPG) is a type of brain tumor that occurs in the lowest, stem-like part of the brain that connects the brain to the spinal cord. Tumors of the brain stem are hard to treat, but it is important to treat them because the brain stem is the area of the brain that controls breathing, blood pressure and heart rate. It is difficult – and often times impossible – to operate on this area of the brain. Currently, the standard treatment for brainstem tumors is radiation therapy, but radiation therapy may only work for a short period of time or may not work at all. DIPGs in children continue essentially incurable. This is a clinical trial to determine the maximum tolerated dose (MTD) vorinostat (SAHA) in combination with radiation therapy and the efficacy of administering vorinostat concurrently with radiation therapy, followed by maintenance therapy with vorinostat, in subjects with newly diagnosed DIPG. Subjects must be more than 36 months and less than 21 years of age at the time of diagnosis with newly diagnosed DIPGs defined also as tumors with a pontine epicenter (brain stem tumors) and diffuse involvement of at least 2/3 of the ponsstructure located in the brain that connects the cerebral cortex (outer part of the brain) with the medulla (lower half of the brainstem) that also serves as communications and coordination center between the two hemispheres of the brain) are eligible without histologic confirmation. It is hoped that subjects will get personal medical benefit from participation in this clinical trial, but cannot be certain. The potential benefits could include getting rid of the cancer for as long as possible. It is expected that the information learned from this study will benefit other patients in the future.

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