Study of the Effect of GM-CSF on Macrophages in Ependymoma

You may be eligible if

• Age \> 12 months and \< 21 years at the time of study enrollment.
• Patients must be one of the following:
• • Newly diagnosed with posterior fossa ependymoma with a subtotal resection at initial surgery. These patients will be eligible for stratum 1.
• * Be in first relapse of their posterior fossa ependymoma. These patients will be eligible for stratum 2.
• Histologically confirmed diagnosis of intracranial ependymoma .
• Pre or post-operative MR imaging of the brain demonstrates no evidence of non-contiguous spread beyond the primary site
• Pre or post-operative MR imaging of the spine demonstrates no evidence of non-contiguous spread beyond the primary site
• Pre-operative CSF cytology obtained from the lumbar CSF space demonstrated no evidence of non-contiguous spread beyond the primary site.
• • The requirement for lumbar CSF examination may be waived if deemed to be medically contraindicated.
• Patients must meet one of the following performance scores.
• • ECOG performance status scores of 0, 1, or 2.
• * Karnofsky score of ≥ 50 for patients \> 16 years of age or Lansky score of ≥ 50 for patients ≤ 16 years of age
• Organ Function Requirements:
• Adequate renal function defined as:
• Creatinine clearance or radioisotope GFR ³ 70ml/min/1.73 m2 or
• A serum creatinine based on age/gender as follows:
• Age Maximum Serum Creatinine (mg/dL) Male Female
• 1 month to \< 6 months 0.4 0.4 6 months to \< 1 year 0.5 0.5
• 1 to \< 2 years 0.6 0.6 2 to \< 6 years 0.8 0.8 6 to \< 10 years 1 1 10 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.4
• ≥ 16 years 1.7 1.4 The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC.
• Adequate liver function defined as:
• Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age, and
• SGOT (AST) or SGPT (ALT) \< 3 x upper limit of normal (ULN) for age.
• Adequate Bone Marrow Function defined as:
• Peripheral absolute neutrophil count (ANC) \>= 1,000/uL
• Platelet count \>= 100,000/uL (transfusion independent).