Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma (NCT02724579)
🩺 Plain-English Summary (8th-Grade Level)
This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (29 items) and avoid the listed exclusions (9 items).
Location: Children's Hospital of Alabama — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar CSF cytology are not eligible; patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible
- Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids
- Pregnancy and Breast Feeding
- Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies
- Lactating females are not eligible unless they have agreed not to breastfeed their infants
- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
- Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
- Patients with a history of moderate to profound intellectual disability (i.e., intelligence quotient \[Q)\]=\< 55) are not eligible for enrollment; PLEASE NOTE: Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a specific learning disability (e.g., dyslexia) are eligible for this study. Children with posterior fossa syndrome (also known as cerebellar mutism) are eligible for this study
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (195 Sites)
- Children's Hospital of Alabama — Birmingham, Alabama
- USA Health Strada Patient Care Center — Mobile, Alabama
- Providence Alaska Medical Center — Anchorage, Alaska
- Banner Children's at Desert — Mesa, Arizona
- Phoenix Childrens Hospital — Phoenix, Arizona
- Arkansas Children's Hospital — Little Rock, Arkansas
- Kaiser Permanente Downey Medical Center — Downey, California
- Loma Linda University Medical Center — Loma Linda, California
- Miller Children's and Women's Hospital Long Beach — Long Beach, California
- Children's Hospital Los Angeles — Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California
- Mattel Children's Hospital UCLA — Los Angeles, California
- Valley Children's Hospital — Madera, California
- UCSF Benioff Children's Hospital Oakland — Oakland, California
- Kaiser Permanente-Oakland — Oakland, California
- Children's Hospital of Orange County — Orange, California
- Lucile Packard Children's Hospital Stanford University — Palo Alto, California
- Sutter Medical Center Sacramento — Sacramento, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- Rady Children's Hospital - San Diego — San Diego, California
- UCSF Medical Center-Mission Bay — San Francisco, California
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California
- Children's Hospital Colorado — Aurora, Colorado
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado
- Connecticut Children's Medical Center — Hartford, Connecticut
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.