Low-Dose Radiation and Combination Chemotherapy Following Surgery in Children With Newly Diagnosed Medulloblastoma
Condition: Brain Tumors; Central Nervous System Tumors; Medulloblastoma
MeSH terms: Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Medulloblastoma
Intervention: Cisplatin; Cyclophosphamide; Etoposide; Lomustine; Vincristine; Craniospinal Radiation
Intervention description: Given at a dose of 70mg/m2 by intravenous (IV) infusion over 8 hours on day 0 of each cycle (Regimen A only).; Given at a dose of 1g/m2/day by IV infusion on days 0 and 1 of a 6-week cycle. Administration of cyclophosphamide will always be preceded by prehydration and Mesna (Regimen B only).; Given at a dose of 150mg/m2/day by IV infusion on days 0 and 1 of a 6-week cycle. Given orally at a dose of 50mg/m2 as a single daily dose for 21 days beginning on day 14 of a cycle (Regimen B only).; Given at a dose of 75mg/m2 taken orally on days 0 of each 6-week cycle with vincristine and cisplatin (Regimen A only).; Given at a dose of 1.5mg/m2 given by IV infusion once a week for the first six weeks of treatment during radiation therapy. During maintenance therapy, it will be given as an IV push on days 0, 7 and 14 of each 6-week cycle (Regimen A only).; Craniospinal radiation will begin within 28 days of surgery. Craniospinal Radiation therapy will last for 6 weeks, five days per week. Once a week during radiation, subjects will also be treated with chemotherapy (vincristine).
Intervention MeSH terms: Cyclophosphamide; Lomustine; Etoposide; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 3 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: average risk medulloblastoma; craniospinal radiotherapy; newly diagnosed

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, but also damages
      normal cells in the developing brains of children. Combining low-dose radiation therapy in
      combination with chemotherapy should be effective in treating medulloblastoma while avoiding
      the long-term side effects of giving higher dose radiation to children with newly diagnosed
      average risk medulloblastoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed medulloblastoma

          2. Standard-risk disease

          3. No residual tumor greater than 1.5 cm^2 after resection by postoperative MRI

               -  No tumor in the spinal or cerebral subarachnoid space by MRI

               -  No tumor in the subarachnoid space by Cerebrospinal fluid (CSF)

               -  No failure to perform staging studies (spine MRI and CSF cytology) preoperatively
                  or postoperatively

          4. Must begin radiotherapy on study within 28 days after surgery

        Exclusion Criteria:

          1. Prior radiotherapy and anti-tumor chemotherapy other than corticosteroids are not
             allowed.

          2. Pregnant females will not be eligible

          3. Patients must begin radiotherapy on protocol within 28 days of completion of surgery.
             Exceptions need to be approved by the Principal Investigator.

          4. Patients with the following will not be eligible:

               -  > 1.5cm3 residual tumor following resection as indicated by post-operative MRI.

               -  tumor in spinal or cerebral subarachnoid space either by MRI of brain and spine

               -  tumor in subarachnoid space by CSF cytology

               -  failure to perform staging studies (spine MRI, CSF cytology) either pre- or post-
                  operatively