Purpose of this Study
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.
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.
Who Can Participate?
Eligibility
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.
-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.
Age Range
0-9
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
This study has two parts.
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)
-MRI scans
-Spinal taps
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
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)
-MRI scans
-Spinal taps
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
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
HEAD START 4 PROTOCOL: Newly Diagnosed Children (Less than 10 Years Old) With Medulloblastoma and Other Central Nervous System Primitive Neuro-Ectodermal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed
Principal Investigator
David
Ashley
Protocol Number
PRO00088766
NCT ID
NCT02875314
Phase
II
Enrollment Status
OPEN TO ACCRUAL