Upstate Active Clinical Trials
Study Title:HEAD START 4 PROTOCOL: Newly Diagnosed Children (Less than 10 Years Old) With Medulloblastoma and Other Central Nervous System Embryonal Tumors. Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation with Randomization to either Single-Cycle or to Three Sequential Cycles of Marrow-Ablative Chemotherapy with Autologous Hematopoietic Progenitor Cell Rescue
What is the purpose of the study?Chemotherapy has temporary but often severe side-effects. All of the drugs used in this study are approved by the US government Food and Drug Administration (FDA) for various kinds of cancers and are commercially available. This research study uses drugs that have been used as treatments for children with brain cancer.
Other aims of this study are:
• To test tumor and blood for markers (molecular) in the DNA that will help us know how to best treat each child on this treatment study.
• To measure any effects that this treatment has on the children’s quality of life (general well-being).
• To measure the brain function of children (measuring intelligence, memory, language, nonverbal skills, attention, and academic achievement) and to examine the relationship between the children’s level of brain function and their quality of life.
• To measure any effects that this treatment has on hearing.
Upstate Institutional Review Board (IRB) Number:975119
Study/Protocol ID:HEAD START 4 PROTOCOL
Study Phase:Phase IV
Patient Age Group:Children
Principal Investigator:Melanie A Comito
Who can I contact for more information?
Name: Karen B Bilynsky