HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

This is an interventional treatment trial for Neoplasms, Brain focused on measuring Brain Tumor, Recurrent, Glioma, Glioblastoma Multiforme, Gliosarcoma, Medulloblastoma, Anaplastic Astrocytoma, Oligodendroglioma, Rhabdoid Tumor, Ependymoma, Germ Cell Tumor, Choroid Plexus Carcinoma, Cerebral Primitive Neuroectodermal Tumor, Giant Cell Glioblastoma, Atypical teratoid/rhabdoid tumor, Secondary Malignant Cerebellar Tumor, Embryonal Tumor, Neoplasms, Oncolytic Virus Therapy, Virotherapy, Oncolytic, Immunotherapy, Central Nervous System Agents, Antineoplastic Agents, Pediatric, Pediatrics, Oncolytic, Virus, HSV, Herpes Virus, G207, Oncolytic Herpes Virus Read More

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 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: The 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.
• Normal hematological, renal and liver function (absolute neutrophil count > 1000/mm3, platelets > 100,000/mm3, 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 m2 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 performance score ≥ 60; patients ≥ 16 years, Karnofsky performance score ≥ 60
• Patient life expectancy must be at least 8 weeks
• Written informed consent in accordance with institutional and FDA guidelines must be obtained from patient or legal guardian

Exclusion Criteria:

• Any treatment outside the allowable guidelines outlined in section 5.1.
• Acute infection, granulocytopenia or medical condition precluding surgery
• Pregnant or lactating females
• Prior history of encephalitis, multiple sclerosis, or other central nervous system 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 HIV seropositivity
• Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, gancyclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone).