Research

CNS Tumor Treatment with SAHA and Isotretinoin - Pilot

A Feasibility Study of SAHA combined with Isotretinoin and Chemotherapy in Infants with Embryonal Tumors of the Central Nervous System

Protocol Description

This Pediatric Brain Tumor Consortium Pilot study tests the use of the drugs isotretinoin and SAHA in combination with other chemotherapy for young patients who have undergone surgery for embryonal tumors of the central nervous system, such as a medulloblastoma or primitive neuroectodermal tumors (PNET). SAHA is suberoylanilide hydroxamic acid, a type of histone deacetylase inhibitor, also called, vorinostat. Laboratory studies suggest that these drugs used together may provide a more effective treatment for high-risk medulloblastoma and PNET than current therapies.

Study Level: Pilot

Eligibility Criteria

Patients of both genders, ages 2 to 48 months, diagnosed with a tumor called medulloblastoma or PNET.
Males: Ages 2 to 48 months
Females: Ages 2 to 48 months

Requirements
Eligible patients will receive SAHA and isotretinoin along with other chemotherapy, a combination of oral and intravenous medications, through 3, 21-day induction courses. At the end of each course, blood stem cells will be collected through apheresis. The stem cells will be reinfused into participants during the subsequent 3, 21-day consolidation courses. Following that, participants will continue with a series of up to 12, 28-day maintenance courses, in which oral doses of medication are taken on a strict schedule.
Frequency of Visits: Weekly with inpatient hospital stays to receive chemotherapy
Duration: Up to 18 months

Status: Open for Enrollment

Source(s) of Support
Pediatric Brain Tumor Consortium (PBTC-026)
National Cancer Institute
Merck and Co.

Additional Resources
Study description at National Institutes of Health