A Phase IB 2 Dose Trial of IRS-1 HSV C134 (IND 17296) Administered Intratumorally in Patients With Recurrent Malignant Glioma

Inclusion Criteria: * Patients must have histologically or cytologically confirmed recurrent/progressive glioblastoma multiforme, Grade 3 or Grade 4 astrocytoma, or gliosarcoma. * Prior therapy. Patients must have failed a course of external beam radiotherapy to the brain at least 4 weeks prior to enrollment. * Age ≥18 years. Because no dosing or adverse event data are currently available on the use of C134 in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials. * Karnofsky Performance Status ≥70%. * Life expectancy of greater than 4 weeks. * Patients must have normal organ and marrow function as defined below: * Leukocytes ≥ 3,000/ μl * absolute neutrophil count ≥ 1,500/ μl * platelets ≥ 100,000/ μl * total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal * Creatinine within normal institutional limits or creatinine clearance≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. * Residual lesion must be ≥1.0 cm in diameter as determined by MRI. * The effects of C134 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the first six months after receiving C134. Because it is currently unknown if C134 can be transmitted by sexual contact, a barrier method of birth con…