Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age

Inclusion Criteria:

• Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), fibrillary astrocytomas (FA), pilomyxoidastrocytoma (PXA), oligodendroglioma, or anaplastic mixed oligoastrocytoma (AOA), orradiologically diagnosed diffuse intrinsic brainstem glioma (DIPG)

• Must have at least one confirmed and evaluable tumor site

• Must have a Karnofsky or Lansky performance status ≥60%.

• No chemotherapy for three weeks prior to treatment

• Patients must have adequate hematologic reserve with absolute neutrophils≥1000/mm3and platelets ≥100,000/ mm3

• Pre-enrollment chemistry parameters must show: bilirubin<1.5x the institutionalupper limit of normal (IUNL); Aspartate Aminotransferase( AST) or Alaninetransaminase (ALT)<2.5x IUNL and creatinine<1.5x IUNL

• Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5x the IUNL

• Growth factor(s): Must not have received within 1 week of entry onto this study

• Steroids: Systemic corticosteroid therapy is permissible in patients with CentralNervous System (CNS) tumors for treatment of increased intracranial pressure orsymptomatic tumor edema. Patients with CNS tumors who are receiving dexamethasonemust be on a stable or decreasing dose for at least 1 week prior to study entry.

• Patients of reproductive age must agree to use a medically effective method ofcontraception during and for a period of three months after the treatment period. Apregnancy test will be performed on each premenopausal female of childbearingpotential immediately prior to entry into the research study

• Patients or their parents/guardians must be able to understand and give writteninformed consent. Informed consent must be obtained at the time of patient screening

• Because of known concerns with Avastin and wound healing, craniotomy patients areeligible for the treatment if they have had a craniotomy greater than two weeksprior to Intra-Arterial (IA) therapy. Craniotomy or major procedure after SIACIAvastin therapy should wait 4 weeks. Minor surgeries may be performed after twoweeks

Exclusion Criteria:

• Females who are pregnant or lactating

• Females of childbearing potential and fertile men will be informed as to thepotential risk of procreation while participating in this research trial and will beadvised that they must use effective contraception during and for a period of threemonths after the treatment period. If they do not agree, they will be ineligible forthe study

• Patients with significant concurrent medical or psychiatric conditions that wouldplace them at increased risk or affect their ability to receive or comply withtreatment or post-treatment clinical monitoring