Head Start 4  ::  Nationwide Children's Hospital

Head Start 4 Randomized Clinical Trial

Since 1990, director of Neuro-Oncology, Dr. Jonathan Finlay has led an innovative approach to brain tumor treatment, serving as principal investigator in a series of three “Head Start” clinical trial protocols.
The Head Start 4 protocol is a randomized clinical trial hosted and coordinated by Nationwide Children’s NEXT Consortium, with other treatment centers participating around the world.  The goals of this study are to determine if the treatment in the protocol will  improve the quality of survival and cure rates for young children (age 10 years or less) newly diagnosed with the most common types of malignant brain tumors in childhood, medulloblastoma and other PNETs (primitive neuro-ectodermal tumors). 
More than 40 institutions throughout the world have agreed to participated in the study including centers in the United States, Canada, Brazil, Australia, the United Kingdom and New Zealand. 
The three previous Head Start research studies to date:
  • Head Start I- conducted 1991-1997
  • Head Start II- conducted 1997-2003
  • Head Start III- started 2003 and is currently ongoing

Treatment Strategy:

The treatment involves testing two strategies: first, reducing the number of induction (initial) chemotherapy cycles from five to three for kids that achieve a complete response after three cycles. This strategy has been initiated to determine if we can sustain the high survival and quality of life in these best risk patients. Second, randomizing high-risk children (those unable to achieve complete responses to Induction chemotherapy or otherwise having high-risk molecular characterstics within their tumors) to either a single cycle or three sequential cycles of high-dose marrow-destructive chemotherapy with blood cell rescue (ie. "transplants"). This strategy seeks to determine if the outcome for these higher risk children can be improved by intensifying treatment with the three transplant cycles of chemotherapy. Molecular prolfiles of each child's tumor will be characterized promptly following diagnosis in order to determine their high-risk or low-risk characteristics, and tailor therapy accordingly. This is the first such prospective treatment study for young children with newly-diagnosed malignant brain tumors to incorporate such a 'personalized' treatment approach.
The study will also be looking at therapy related hearing loss, long term neuropsychological, hormonal and physical growth in children treated on this protocol.
For further information on the Head Start clinical trials at Nationwide Children's Hospital please contact HeadStart4@NationwideChildrens.org.

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Head Start 4 Clinical Trial

Nationwide Children’s is currently conducting a new study for children with brain tumors. Enrollment is now open for the Head Start 4 Clinical Trial.  

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