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Protocol No. ACNS1422

Principal Investigator DeSantes, Kenneth

Phase II

Age Group Both

Scope National

Sponsor Type National

Title A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

Objective Recent studies using a combination of chemotherapy and radiation therapy to treat children with WNT subtype medulloblastoma have been > 90% effective in curing this disease. However, there is concern about the late effects of such treatment. Late effects are problems that arise later in life after treatment is completed such as learning difficulties, lower amounts of hormones, hearing problems or other problems in performing daily activities. Two ways that study doctors would like to try to reduce late effects is to give a smaller dose of radiation therapy and less chemotherapy than is normally used. The overall goal of this study is to find out if a reduced dose of radiation to the whole brain and spine and less chemotherapy can be given to children and young adults with WNT subtype medulloblastoma without increasing the risk of the tumor coming back. The combination of a reduction in radiation therapy and chemotherapy is experimental.

Treatment The treatment involves radiation therapy followed by cancer fighting medicine called chemotherapy

Key Eligibility
  • Must be greater than or equal to 3 years and less than 22 years at the time of enrollment
  • Must be newly diagnosed and have: • Eligibility confirmed by rapid central pathology and molecular screening review on APEC14B1
  • Must have negative lumbar CSF cytology
  • Must have adequate bone marrow function, adequate renal function, adequate liver function and adequate central nervous system function
  • 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
  • Can not be pregnancy and breast feeding
  • Patients with a history of moderate to profound intellectual disability (i.e. IQ < 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

  • Applicable Disease Sites Brain/Central Nervous System

    Status Open

    Participating Institutions Gundersen Health System; UW Hospital and Clinics