HEAD START 4 PROTOCOL
What is the Purpose of this Study?
In Part 1 we will ask your child to:
-Have their tumor tested for markers that will help doctors know how to best treat each child's tumor
-Have 3 cycles (21-28 days each cycle) of chemotherapy (5 cycles if there is still some tumor remaining)
-Have a procedure where your blood is taken out of a vein in one arm, goes through a machine that takes out white blood cells, and returns the blood back into a vein in the other arm (called leukapheresis)
Part 2 will be based on the results of the tumor marker tests. During this part, we will ask your child to:
-Be randomized (like flipping a coin) to receive either 1 or 3 cycles (21 days per cycle) of consolidation chemotherapy
-Have a single cycle (21-42 days) of consolidation chemotherapy if they have low-risk medulloblastoma
-Have an infusion of their own stem cells to help the blood-forming system re-establish itself
-Have radiation therapy if there is residual tumor tissue despite the treatment
Who Can Participate in this Study?
Children, less than 10 years old at diagnosis, who:
-Are newly diagnosed with medulloblastoma or another embryonal tumor in the brain or spinal cord
-Have not have had chemotherapy or radiation therapy before
For more information about who can be in this study, please contact the study team.
What is Involved?
We are doing this study to compare two different treatments to see which is better for treating children with this type of brain cancer. The drugs in this study have all be used to treat children with brain cancer, what is new is the way they are being given.
In addition to comparing how well these treatments work, we will evaluate their effects on each child's quality of life, brain function, and hearing.
CLINICAL AND MOLECULAR RISK-TAILORED INTENSIVE AND COMPRESSED INDUCTION CHEMOTHERAPY FOLLOWED BY CONSOLIDATION WITH EITHER SINGLE CYCLE (LOW RISK PATIENTS) OR RANDOMIZATION (HIGH RISK PATIENTS) TO either SINGLE-CYCLE or TO THREE TANDEM CYCLES OF MARROW-ABLATIVE CHEMOTHERAPY WITH AUTOLOGOUS HEMATOPOIETIC PROGENITOR