HEAD START 4 PROTOCOL (Pediatric Brain Cancer)

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 been used to treat children with brain cancer, but 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.

Who Can Participate?

Eligibility

Children who:
  • Are newly diagnosed with medulloblastoma or another embryonal tumor in the brain or spinal cord
  • Were less than 10 years old at their time of diagnosis
  • Have not have had chemotherapy or radiation therapy before
For more information about who can be in this study, please contact the study team at 919-684-5301.

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?

Description

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 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

IV

Enrollment Status

Open to Enrollment
ClinicalTrials.gov