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A Prospective, Multi-Center Trial of NovoTTF-100A Together with Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM.
Open to Accrual
Chemotherapy: Systemic, Other
Defintions of terms and FAQ about clinical trials.
Thomas Chen, M.D.
Other Trial Staff:
Anush Arakelyan, D.M.
to see study documents.
You may participate in this study if:
Pathological evidence of GBM using WHO classification criteria.
greater than or equal to 18 years of age.
Received maximal debulking surgery and radiotherapy with Temozolomide.
Karnofsky scale greater than or equal to 70
Life expectancy at least 3 months
Participants of childbearing age must use effective contraception.
Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms.
Treatment start date at least 4 weeks out from surgery.
Treatment start date at least 4 weeks out but not more than 7 weeks from last dose of adjuvant Temozolomide.
Treatment start date at least 4 weeks out from radiation therapy.
You may not participate in this study if:
Actively participating in another clinical treatment trial
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)
Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias.
Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC.
For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or
To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.