A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients
Study on Reduced Radiation and Chemotherapy for WNT-driven (a type of genetic alteration associated with medulloblastoma) Medulloblastoma
Brief description of study.
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Untreated Childhood Medulloblastoma,Medulloblastoma ,pediatric,riley,kid,kids,child,children,teen,teens,teenager,teenagers,adolescent,youth
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Age: 3 years - 21 years
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Gender: All
Patients must be newly diagnosed and have a confirmed molecular diagnosis of classical histologic type WNT medulloblastoma from rapid central pathology screening review on APEC14B
Patient must have negative lumbar cerebrospinal fluid (CSF) cytology
Patients must have eligibility confirmed by rapid central imaging review on APEC14B1
Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1422
Patients must be enrolled within 36 days of definitive diagnostic surgery
Patients must have no previous radiotherapy or chemotherapy other than corticosteroids
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 tumor-directed therapy other than surgical intervention and corticosteroids
Female patients who are pregnant are ineligible
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
This study investigates how well reduced doses of radiation therapy and chemotherapy work in treating patients with a type of brain tumor called WNT-driven medulloblastoma. Medulloblastoma is a cancerous brain tumor that starts in the lower back part of the brain and can spread to other areas. The study aims to find out how effective this treatment is in preventing the tumor from growing or spreading in children aged 3 years and older.
Participants in the study will receive a lower dose of radiation therapy to the brain and spine, specifically 18 Gray (Gy) with an additional boost of 36 Gy to the tumor area, making a total of 54 Gy. The chemotherapy given will also be reduced, with no vincristine used during radiation therapy and a lower dose during maintenance treatment. These procedures are designed to see if they can effectively manage the disease while minimizing side effects.
- Who can participate: Children 3 years and older with newly diagnosed WNT-driven medulloblastoma can participate. Key eligibility includes a confirmed diagnosis, negative cerebrospinal fluid cytology, and no previous treatments except surgery and corticosteroids.
- Study details: Participants will undergo reduced radiation therapy and chemotherapy. Radiation will be given in lower doses to the brain and spine, and chemotherapy will be reduced, excluding vincristine during radiation. A placebo will not be used in this study.
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