Oncolytic HSV-1 G207 in Patients with Recurrent or Refractory Cerebellar Brain Tumors

Inclusion Criteria

• Age >= 36 months and < 19 years
• Pathologically proven malignant cerebellar brain tumor (including medulloblastoma, glioblastoma multiforme, giant cell glioblastoma, anaplastic astrocytoma, primitive neuroectodermal tumor, ependymoma, atypical teratoid/rhabdoid tumor, germ cell tumor, or other high-grade malignant tumor) which is progressive or recurrent despite standard care including surgery, radiotherapy, and/or chemotherapy. A pathologically proven secondary malignant cerebellar tumor without curative treatment options is eligible
• Lesion must be >= 1.0 cm =< 3.0 cm in diameter and surgically accessible as determined by magnetic resonance imaging (MRI). Larger tumors may be surgically debulked and treated if =< 3.0 cm after debulking
• Patients must have fully recovered from acute treatment related toxicities of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study
• Myelosuppressive chemotherapy: patients must have received their last dose at least 3 weeks prior (or at least 6 weeks if nitrosurea)
• Investigational/Biologic agents: patients must have recovered from any acute toxicities potentially related to the agent and received last dose >= 7 days prior to entering this study (this period must be extended beyond the time during which adverse events are known to occur for agents with known adverse events >= 7 days). For viral therapy, patients must have received viral therapy >= 3 months prior to study entry and have recovered from all acute toxicities potentially related to the agent
• Monoclonal antibodies: patient must have received last dose >= 21 days prior
• Radiation: patients must have received their last fraction of craniospinal radiation (> 24 Gy) or total body irradiation >= 3 months prior to study entry. Patients must have received focal radiation to symptomatic metastatic sites or local palliative radiation >= 28 days prior to study entry
• Autologous bone marrow transplant: patients must be >= 3 months since transplant prior to study entry
• Absolute neutrophil count >= 1000/mm^3
• Platelets >= 100,000/mm^3
• Prothrombin time (PT) or partial thromboplastin time (PTT) =< 1.3 x control
• Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
• Total bilirubin =< 1.5 mg/dl
• Transaminases =< 3 times above the upper limits of the institutional norm
• Patients < 16 years, Modified Lansky score >= 60; patients >= 16 years, Karnofsky score >= 60
• Patient life expectancy must be at least 8 weeks
• Written informed consent in accordance with institutional and Food and Drug Administration (FDA) guidelines must be obtained from patient or legal guardian

Exclusion Criteria

• Any treatment outside the allowable guidelines outlined
• Acute infection, granulocytopenia or medical condition precluding surgery
• Pregnant or lactating females
• Prior history of encephalitis, multiple sclerosis, or other central nervous system (CNS) infection
• Tumor involvement which would require ventricular or brainstem inoculation or would require access through a ventricle in order to deliver treatment
• Required steroid increase within 1 week prior to injection
• Known human immunodeficiency virus (HIV) seropositivity
• Concurrent therapy with any drug active against herpes simplex virus (HSV) (acyclovir, valacyclovir, penciclovir, famciclovir, gancyclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone)