Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma
Condition: Brain Tumor; Central Nervous System Tumor
MeSH terms: Ependymoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: filgrastim; carboplatin; cyclophosphamide; etoposide; vincristine sulfate; radiation therapy; Mesna; therapeutic conventional surgery
Intervention description: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.; Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patients with BSA <0.45m2 the dose is 12.5 mg/kg/day.; Given IV (1000mg/m2/day) Day 1 and 2 given as an IV infusion over one hour following carboplatin administration. For patients with BSA<0.45m2 the dose is 33mg/kg/day on Day 1 and 2.; Given orally (50 mg/m2/day) orally once daily on Days 1 through 21. For patients with BSA < 0.45 m2, the dosage is 1.7 mg/kg/day on Days 1 through 21.; Given IV or orally (1.5mg/m2/day) (maximum dose 2 mg) Day 1 and 8 given as IV bolus. For patients with BSA<0.45m2 the dose is 0.05mg/kg.; Given once daily 5 days a week for 6-6½ weeks; Mesna (200mg/m2/dose) Day 1 and 2. For patients with BSA<0.45m2 the dose is (7mg/kg/dose). Combine mesna (200mg/m2) with cyclophosphamide and administer intravenously over one hour followed by mesna (200mg/m2) in 375 cc/m2 D5-1/2NS and run intravenously over 3 hours at 125cc/m2/hr. After 3 hour mesna, administer mesna (200 mg/m2/dose) IV over 15 minutes at hour 5.
Intervention MeSH terms: Cyclophosphamide; Carboplatin; Etoposide; Vincristine; Podophyllotoxin; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 378.0
Sex: All
Minimum age: 1 Year
Maximum age: 21 Years
Healthy volunteers: No
Keywords: childhood supratentorial ependymoma; newly diagnosed childhood ependymoma; childhood infratentorial ependymoma

Summary:

      RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to
      the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during
      surgery.

      PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapy
      either alone or after chemotherapy and second surgery in treating children who have undergone
      surgery for localized ependymoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed intracranial ependymoma

               -  Differentiated ependymoma or anaplastic ependymoma

          -  No primary spinal cord ependymoma, myxopapillary ependymoma, subependymoma,
             ependymoblastoma, or mixed glioma

          -  No evidence of noncontiguous spread beyond primary site

          -  Initial surgical resection within the past 56 days

        PATIENT CHARACTERISTICS:

        Age:

          -  1 to 21

        Performance status:

          -  No restrictions

        Life expectancy:

          -  At least 2 months

        Hematopoietic:

          -  Not specified

        Hepatic:

          -  Not specified

        Renal:

          -  Not specified

        Other:

          -  Able to undergo MRI

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  No prior chemotherapy

        Endocrine therapy:

          -  Prior or concurrent corticosteroids allowed

        Radiotherapy:

          -  No prior radiotherapy

        Surgery:

          -  See Disease Characteristics

          -  More than 1 prior surgery allowed

        Other:

          -  No other prior treatment for ependymoma