IL-12-Expressing HSV-1 in Treating Patients with Recurrent or Progressive Glioblastoma, Anaplastic Astrocytoma, or Gliosarcoma

Inclusion Criteria

• Patients must have histologically or cytologically confirmed glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma
• Patients must have failed external beam radiotherapy >= 5,000 cGy to the brain, and if eligible and tolerated, undergone appropriate treatment with temozolomide chemotherapy; all radiation and additional chemotherapies must have been completed at least 4 weeks prior to enrollment; prior therapy with nitrosoureas must have been completed at least 6 weeks prior to enrollment
• Karnofsky performance status (KPS) >= 70%
• Life expectancy of greater than 4 weeks
• Leukocytes >= 3,000/ul
• Absolute neutrophil count >= 1,500/ul
• Platelets >= 100,000/ul
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
• Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
• Residual lesion must be >= 1.0 cm in diameter as determined by magnetic resonance imaging (MRI)
• 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 M032; a barrier method of birth control must be employed and for six (6) months following the administration of the study drug; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; for two weeks after receiving M032, subjects should avoid intimate contact with pregnant women, infants and young children and individuals with decreased immunity (ability to fight infection); subjects should also refrain from donating blood during the trial
• Ability to understand and the willingness to sign a written informed consent document
• Females of childbearing potential must not be pregnant; this will be confirmed by a negative serum pregnancy test within 14 days prior to starting study treatment
• Steroid use is allowed as long as dose has not increased within 2 weeks of scheduled M032 administration; whenever possible, the patient should be on a steroid dose that is equivalent to a dexamethasone dose of =< 2 mg daily at the time of treatment

Exclusion Criteria

• Patients who have had chemotherapy, cytotoxic therapy, immunotherapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas), surgical resection within 4 weeks prior to entering the study, or have received experimental viral therapy or gene therapy at any time (e.g., adenovirus, retrovirus or herpes virus protocol); however, this does not preclude re-treatment with M032 at a later date
• Patients who have not recovered from adverse events due to therapeutic interventions administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar biologic composition to M032 or to IL-12
• Tumor involvement which would require ventricular, brainstem, basal ganglia, or posterior fossa inoculation or would require access through a ventricle in order to deliver treatment
• Prior history of encephalitis, multiple sclerosis, or other central nervous system (CNS) infection
• Required steroid increase within 2 weeks of scheduled M032 administration; when possible, the patient should be on a dexamethasone equivalent dose of =< 2 mg daily at the time of treatment
• Active herpes lesion
• Concurrent therapy with any drug active against simplexvirus (HSV) (acyclovir, valacyclovir, penciclovir, famcyclovir, gancyclovir, foscarnet, cidofovir)
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other medical condition that precludes surgery; also, psychiatric illness/social situations that would limit compliance with study requirements
• Excluded patient groups: * Pregnant women are excluded from this study; breastfeeding women will not be included in the study * Human immunodeficiency virus (HIV)-seropositive patients are excluded from this study
• Patients with known history of allergic reaction to intravenous (IV) contrast material that is not amenable to pre-treatment by University of Alabama at Birmingham (UAB) protocol
• Patients with pacemakers, ferro-magnetic aneurysm clips, metal infusion pumps, metal or shrapnel fragments or certain types of stents
• Receipt of Gliadel therapy
• Receipt of bevacizumab (Avastin) therapy within 4 weeks of scheduled M032 administration; (receipt of bevacizumab [Avastin] greater than 4 weeks of scheduled M032 administration does not exclude patient)