Subventricular Zone (SVZ) and Temozolomide in Glioblastoma Multiforme

Inclusion Criteria:

• Patient must have newly diagnosed, histologically confirmed GBM.

• Patient must have undergone gross total resection, subtotal resection, or biopsywith the extent of resection determined by the treating neurosurgeon, and must beginradiation within 12 weeks of this procedure.

• Patients must not have received previous irradiation to the brain.

• Patient must be at least 18 years of age since the diagnosis of GBM in patientsyounger than 18 is rare and accurate evaluation of neurocognitive function wouldrequire a different battery of examinations than employed in this study.

• ECOG performance status 0-2 (Karnofsky >60%; see Appendix A).

• Patient must be scheduled to receive temozolomide concurrent with and followingradiation (temozolomide may be started late due to insurance reasons, insufficientcounts, or other reasons).

• If a woman is of child-bearing potential, a negative urine or serum pregnancy testmust be demonstrated prior to treatment. Women of childbearing potential and menmust agree to use adequate contraception (hormonal or barrier method of birthcontrol; abstinence) for the duration of study participation and for up to 12 weeksfollowing the study. Should a women become pregnant or suspect she is pregnant whileparticipating in this study she should inform her treating physician immediately.

• Patient must have the ability to understand and the willingness to sign a writteninformed consent document.

• All patients must be informed of the investigational nature of this study and mustbe given written informed consent in accordance with institutional and federalguidelines.

• Radiation therapy must begin within 12 weeks of surgery.

Exclusion Criteria:

• No prior malignancy is allowed except for adequately treated basal cell or squamouscell skin cancer, cervical carcinoma in situ, or other cancer from which the patienthas been disease free for at least 2 years.

• Patients with uncontrolled intercurrent illness including, but not limited to,ongoing or active infection, symptomatic congestive heart failure, unstable anginapectoris, cardiac arrhythmia, or psychiatric illness/social situations that wouldlimit compliance with study requirements will be excluded.

• Pregnant and breastfeeding women are excluded. Women of child-bearing potential whoare unwilling or unable to use an acceptable method of birth control to avoidpregnancy for the entire study period and up to 12 weeks after the study areexcluded. This applies to any woman who has not experienced menarche and who has notundergone successful surgical sterilization or is not postmenopausal (defined asamenorrhea for at least 12 consecutive months). Male subjects must also agree to useeffective contraception for the same period as above.

• Use of Avastin or another VEG-F inhibitor prior to progression is not permitted.