| | Requirement |
| 1 | Pathological evidence of GBM using WHO classification criteria. |
| 2 | greater than or equal to 18 years of age. |
| 3 | Received maximal debulking surgery and radiotherapy with Temozolomide. |
| 4 | Karnofsky scale greater than or equal to 70 |
| 5 | Life expectancy at least 3 months |
| 6 | Participants of childbearing age must use effective contraception. |
| 7 | Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms. |
| 8 | Treatment start date at least 4 weeks out from surgery. |
| 9 | Treatment start date at least 4 weeks out but not more than 7 weeks from last dose
of adjuvant Temozolomide. |
| 10 | Treatment start date at least 4 weeks out from radiation therapy. |
| 1 | Progressive disease. |
| 2 | Actively participating in another clinical treatment trial |
| 3 | Pregnant |
| 4 | Significant co-morbidities at baseline which would prevent maintenance
Temozolomide treatment:
1. Thrombocytopenia (platelet count < 100,000)
2. Neutropenia (absolute neutrophil count < 1,500)
3. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
4. Significant liver function impairment - AST or ALT > 3 times the upper limit of
normal
5. Total bilirubin > upper limit of normal
6. Significant renal impairment (serum creatinine > 1.7) |
| 5 | Implanted pacemaker, defibrillator or deep brain stimulator, or documented
clinically significant arrhythmias. |
| 6 | Infra-tentorial tumor |
| 7 | Evidence of increased intracranial pressure (midline shift > 5mm, clinically
significant papilledema, vomiting and nausea or reduced level of consciousness) |
| 8 | History of hypersensitivity reaction to Temozolomide or a history of
hypersensitivity to DTIC. |
