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

S
Sandeep Batra, MD

Primary Investigator

Overview

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.

Description

The purpose of this study is to estimate the progression-free survival (PFS) of children >= 3 years of age with wingless-type MMTV integration site family (WNT)/WNT-driven average-risk medulloblastoma using reduced craniospinal radiotherapy (CSI) (18 Gray [Gy]) with a limited target volume boost to the tumor bed of 36 Gy for a total of 54 Gy and reduced chemotherapy approach (no vincristine [vincristine sulfate] during radiotherapy and reduced-dose maintenance chemotherapy) and to monitor the PFS for early evidence that the outcome is unacceptable.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Medulloblastoma,Untreated Childhood Medulloblastoma
  • Age: Between 3 Years - 21 Years
  • Gender: All

Inclusion Criteria
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
Additional Information:
Participants will not be paid for their participation.

Updated on 09 Mar 2024. Study ID: 1710816277 (PHO-PRADHAN-COG-ACNS1422)

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