HSV G207 Alone or With a Single Radiation Dose in Children With Progressive or Recurrent Supratentorial Brain Tumors

Korábbi kezelés

• Prior history of encephalitis, multiple sclerosis, or other central nervous system (CNS) infection
• Required steroid increase within 1 week prior to injection
• Concurrent therapy with any drug active against HSV (acyclovir, valaciclovir, penciclovir, famciclovir, gancyclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone).

Más betegség

• Acute infection, granulocytopenia or medical condition precluding surgery
• Known HIV seropositivity

Egyéb

• Pregnant or lactating females
• Tumor involvement which would require ventricular, cerebellar or brainstem inoculation or would require access through a ventricle in order to deliver treatment

• Age ≥ 36 months and \< 19 years
• Pathologically proven malignant supratentorial brain tumor (including 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 tumor without curative treatment options is eligible.
• Lesion must be \> 1.0 cm in diameter and surgically accessible as determined by MRI
• 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.
• 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 \> 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 \< 10 years, Modified Lansky score ≥ 60; patients \> 10 years, Karnofsky 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