Participants enrolling on this study will receive standard of care chemotherapy for Wnt positive medulloblastoma without the radiation therapy or the weekly chemotherapy that is given during radiation therapy.
There will be 9 cycles of chemotherapy. There are two different kinds of cycles given. They are referred to as A and B. Cycle A lasts for 6 weeks and Cycle B lasts for 4 weeks. B cycles are given after the completion of two A cycles. Below are the details of the drugs and schedules for A and B cycles. Cycle A (This cycle lasts 42 days) * Lomustine (CCNU) is given by mouth on Day 1. * Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15. * Cisplatin is given directly into a vein over 8 hours on Day 1 Cycle B (This cycle lasts 28 days) * Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2. * MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours. * Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8. You may also get a supportive care drug called a myeloid growth factor (filgrastim or pegfilgrastim). This drug will help your blood counts recover after the chemotherapy is given.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1.
Chemotherapy Cycle A Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15.
Chemotherapy Cycle A Cisplatin is given directly into a vein over 8 hours on Day 1.
Phoenix Childrens Hospital Hematology/Oncology
Phoenix, Arizona, United States
Children's Hospital Colorado Center for Cancer & Blood Disorders
Progression Free Survival
To determine the feasibility of treating newly diagnosed children with non-metastatic, standard risk, Wnt positive medulloblastoma with a chemotherapy-only approach. Primary outcome measure of this study will be progression-free survival; the number of participants who with progression free survival.
Time frame: 3 years
Patterns of Failure
To evaluate the patterns of failure in those children that do not have progressive disease, progression free survival and overall survival.
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Chemotherapy Cycle B Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2.
Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours.
Chemotherapy Cycle B Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8.
Aurora, Colorado, United States
M D Anderson Cancer Center-Orlando Pediatric Hematology/Oncology
Orlando, Florida, United States
All Children's Hospital Pediatric Hematology/Oncology
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta- Egleston Pediatric Neuro-Oncology
Atlanta, Georgia, United States
Ann and Robert H Lurie Children's Hospital of Chicago Hematology/Oncology
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine Pediatric Hematology/Oncology
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
...and 6 more locations