HEAD START 4 (Brain Tumor) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Brain tumor (newly diagnosed medulloblastoma) and spinal cord tumors

Who Can Participate in the 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.

Age Group
Children

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

Study Details

Full Title
The "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 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 CELL RESCUE
Principal Investigator
Protocol Number
IRB: PRO00088766
NCT: NCT02875314
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698