Viral Therapy in Treating Young Patients With Relapsed or Refractory Solid Tumors

PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of REOLYSIN (wild-type reovirus) administered as an intravenous infusion daily for 5 days, every 28 days to children with relapsed or refractory solid tumors. II. To define and describe the toxicities of Reolysin in these patients. III. To define the toxicity and tolerability of combining Reolysin with oral cyclophosphamide in these patients. IV. To characterize the pharmacokinetics (time course of viral clearance) of Reolysin in children with refractory cancer. SECONDARY OBJECTIVES: I. To define the antitumor activity of Reolysin within the confines of a phase I study. II. To evaluate the development of neutralizing antibodies to Reolysin following intravenous administration of Reolysin alone and in combination with cyclophosphamide. III. To assess the biologic activity of Reolysin. OUTLINE: This is a dose-escalation study of wild-type reovirus. Patients receive wild-type reovirus intravenously (IV) over 60 minutes once daily (QD) on days 1-5. Some patients also receive cyclophosphamide orally (PO) on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for up to 1 year.