Study Assessing the Feasibility of a Surgery and Chemotherapy-Only in Children With Wnt Positive Medulloblastoma

Status: Recruiting
Phase: N/A
DFCI Protocol ID:

Participants enrolling on this study will receive standard of care chemotherapy for Wnt positive medulloblastoma without the radiation therapy or the weekly chemotherapy that is given during radiation therapy.

Conducting Institutions:

Children's Hospital Boston, Dana-Farber Cancer Institute

Overall PI:

Pratiti Bandopadhayay, MBBS, PhD, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria:

  -  Participants must have classical histology posterior fossa medulloblastoma as
     determined by institutional neuro-pathological evaluation.

  -  Institutional beta- catenin staining must demonstrate nuclear reactivity by
     immunohistochemistry

  -  Sufficient pathologic material must be available for central analysis and review

  -  Tumors will be deemed Wnt positive if, at the time of central analysis, there is:

  -  Confirmation of beta-catenin nuclear reactivity by immunohistochemistry.

  -  Monosomy 6 as determined by array CGH

  -  Absence of MYCN or MYC amplification (as determined by FISH)

  -  Absence of large-cell, anaplastic histology

  -  Absence of residual or disseminated disease as defined by the following criteria:
     Minimal residual disease as determined by post-operative imaging preferably performed
     within 48 hours of resection (and at most 28 days post-surgery), i.e. gross total
     resection or residual disease of <1.5cm2 on post-operative imaging.

No evidence of metastatic disease in the brain, spine or cerebral spinal fluid (CSF).
Assessments must include MRI imaging of the brain and spine with and without contrast and
a lumbar puncture for CSF cytology

  -  Patients must not have had any radiation therapy or chemotherapy for medulloblastoma
     prior to study enrollment

  -  Patients must have a Lansky performance status of >/=30 for children </=10 years of
     age or a Karnofsky performance status of > 30 for children > 10 years of age.

  -  Participants must have normal organ and marrow function as defined below:

  -  Hemoglobin greater than 10 g/dL (can be transfused). Hemoglobin <10 g/dL due to
     operative blood loss is permitted.

  -  Absolute neutrophil count > 1.0x109/L

  -  Platelets > 100,000/uL (non-transfused)

  -  Total bilirubin <1.5 x upper limit normal

  -  SGOT (AST) or SGPT (ALT) <2.5 x upper limit normal (ULN) for age

  -  Creatinine clearance or radioisotope GFR >70 ml/min/1.73m2 or normal serum creatinine
     for patient's age and gender

  -  All females of child-bearing age must have a negative pregnancy test before being
     enrolled on study. All patients of child-bearing age must practice an effective
     method of birth control whilst undergoing chemotherapy on study.

  -  No history of allergic reactions attributed to compounds of similar chemical or
     biologic composition to cisplatin, lomustine, vincristine or cyclophosphamide.

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