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Complete title: A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM
|Research Study Number||20090487|
|Principal Investigator||Maciej Mrugala, MD, PhD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- 1. Pathological evidence of GBM using WHO classification criteria.
- 2. > 18 years of age.
- 3. Received maximal debulking surgery and radiotherapy concomitant with Temozolomide (45-70Gy):
-- ** a. Patients may enroll in the study if received Gliadel wafers before entering the trial
-- ** b. Any additional treatments received prior to enrollment will be considered an exclusion.
-- ** c. Minimal dose for concomitant radiotherapy is 45 Gy
- 4. Karnofsky scale =/> 70
- 5. Life expectancy at least 3 months
- 6. Participants of childbearing age must use effective contraception.
- 7. All patients must sign written informed consent.
- 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 the later of last dose of concomitant Temozolomide or radiotherapy.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 2. Actively participating in another clinical treatment trial
- 3. Pregnant
- 4. Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:
-- ** a. Thrombocytopenia (platelet count < 100 x 103/µL)
-- ** b. Neutropenia (absolute neutrophil count < 1.5 x 103/µL)
-- ** c. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
-- ** d. Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
-- ** e. Total bilirubin > upper limit of normal
-- ** f. Significant renal impairment (serum creatinine > 1.7 mg/dL)
- 5. Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, 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.
Other exclusion criteria may apply.
Brain Cancer; Solid Tumors
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