Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors

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PRIMARY OBJECTIVES: I. To define the maximum tolerated dose (MTD) and describe the toxicities of wild-type reovirus (Reolysin) when given once a day for three days following two days of treatment with sargramostim (GM-CSF). SECONDARY OBJECTIVES: I. To assess the safety, tolerability and adverse even...

PRIMARY OBJECTIVES: I. To define the maximum tolerated dose (MTD) and describe the toxicities of wild-type reovirus (Reolysin) when given once a day for three days following two days of treatment with sargramostim (GM-CSF). SECONDARY OBJECTIVES: I. To assess the safety, tolerability and adverse events in the patient population. II. To assess the median overall survival time in this patient population. III. To assess the median progression free survival time in this patient population. TERTIARY OBJECTIVES: I. To determine whether there is a correlation between antibody responsiveness to the virus and a positive tumor response to Reolysin in patients who receive the virus following treatment with GM-CSF. II. To determine whether there is a correlation between an increased number of circulating monocytes and a positive tumor response to Reolysin in patients who receive the virus following treatment with GM-CSF. III. To explore the possible predictive value of monocyte numbers in response to Reolysin + GM-CSF therapy. OUTLINE: This is a dose-escalation study of wild-type reovirus. Patients receive sargramostim subcutaneously (SC) daily on days 1 and 2 and wild-type reovirus intravenously (IV) over 60 minutes on days 3-5. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for up to 2 years.

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