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Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal


Title ACNS0334, A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs. the Same Therapy without Methotrexate
Therapeutic Area Brain Tumors (Pediatric)
Principal Investigator Michael J. Kelly, MD
Max Age 3 Years
Gender Both
Contact Jennifer Truong
617-636-8885
More Information http://clinicaltrials.gov/ct2/show/NCT00336024

Overview

The overall goal of this study is to compare the effects, good and/or bad of induction therapy that includes methotrexate with induction therapy that does not include methotrexate on infants with high-risk medulloblastoma/PNET to find out which is better.

Study Details

Inclusion Criteria

  • Children less than 36 months (3 years) of age at time of definitive surgery who have high risk Medulloblastoma 
  • Children less than 36 months (3 years) of age at the time of definitive surgery with supratentorial PNET (any M-Stage) 
  • Children with anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor.

Exclusion Criteria

  • Prior radiation therapy or chemotherapy other than corticosteroids 
  • Inadequate renal, liver, cardiac, pulmonary, and bone marrow functions

Study Requirements

Participants will be randomized into two different regimens, A nd B. 
Regimen A:  Induction with vincristine, etoposide, cyclophosphamide, and cisplatin; with or without surgery; and consolidation with stem cell rescue 
Regimen B:  Induction with vincristine, etoposide, cyclophosphamide, cisplatin, and methotrexate; with or without surgery; and consolidation with stem cell rescue.Participants on this study will be followed up to ten years.
Nurse navigators for cancer patients at Tufts Medical Center.

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