Treatment of Newly Diagnosed Brain Tumors With Chemotherapy and Radiation Using Cells Modified for Chemoprotection and an Experimental Drug to Decrease the Tumor Cell Resistance to Chemotherapy

Inclusion Criteria

• •3.1.1 Age \> 5 years and \< 55 years. NOTE: Subjects ages 5-30 are eligible to be treated at Cincinnati Children's Hospital Medical Center; subjects over age 30 will be treated at Ohio State University Comprehensive Cancer Center.
• •3.1.2 Anticipated life expectancy of at least nine months 3.1.3 Karnofsky score \> 50 for patients \> 10 years of age, and Lansky score \> 50 for patients \< 10 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
• •3.1.4 Patients must have one of the following newly-diagnosed central nervous system tumors, confirmed by histologic verification: Glioblastoma multiforme (WHO grade IV) OR Anaplastic astrocytoma (WHO grade III)
• •3.1.5 Patients older than 30 years that have undergone a gross total resection and who do not have measurable disease on post operative MRI; measurable disease as assessed by post operative MRI is required on patients 30 years of age or younger.
• •3.1.6 Neurologic deficits and corticosteroid doses must be stable or decreasing at the time of study entry.
• •3.1.7 Adequate organ function as defined by: Serum creatinine \< upper limit of normal, or GFR \> 70 ml/min/1.73 m2 Total bilirubin \< 2.0 mg/dl; SGPT (ALT) AND SGOT (AST) \< 2.5x upper limit of normal; serum albumin \> 2.0 g/dL Absolute neutrophil count \> 1,000/µl, platelet count \> 75,000/µl independent of transfusions
• •3.1.8 The patient and/or the patient's legally authorized guardian must give written informed consent according to local Institutional and/or University Human Experimentation Committee requirements.
• •3.1.9 Women or men with reproductive potential must use effective contraception throughout the study. Effective contraception methods for women would include either an oral or transdermal contraceptive, injectable contraceptive (e.g., Depo-Provera), or contraceptive implants (e.g., intrauterine device). All males on study must agree to the use of condoms during intercourse.
• •3.1.10 Women of reproductive potential must have a negative serum pregnancy test.