Active — Not RecruitingPhase 2

Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma

United States45 participantsStarted 2017-11-17

Plain-language summary

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 participate

Age range3 Years – 21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must be greater than or equal to 3 years and less than 22 years of age at the time of enrollment * Patients must be newly diagnosed and have: * Eligibility confirmed by rapid central pathology and molecular screening review on APEC14B1: * Classical histologic type (non LC/A) WNT medulloblastoma * Positive nuclear beta-catenin by immunohistochemistry (IHC) * Positive for CTNNB1 mutation by Sanger sequencing * Negative for MYC and MYCN by fluorescence in situ hybridization (FISH) * Patient must have negative lumbar cerebrospinal fluid (CSF) cytology * Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF; ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study; patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status; patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated; patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively * Patients must have eligibility confirmed by Rapid Central Imaging Review on APEC14B1; patients must have =\< 1.5 cm\^2 maximal cross-sectional area of residual tumor; whole brain magnetic resonance imaging (MRI) with and without gadoliniu…

What they're measuring

Progression-free survival (PFS)

Timeframe: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 10 years

Trial details

NCT IDNCT02724579

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2028-03-31