University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial 6G-08-1


A Prospective, Multi-Center Trial of NovoTTF-100A Together with Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM.

Type: Cancer Therapy
Phase: Phase III
Status: Open to Accrual
Treatments: Chemotherapy: Systemic, Other
Randomized: Yes
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  Thomas Chen, M.D.
Other Trial Staff:  Anush Arakelyan, D.M.

Staff may log in to see study documents.


You may participate in this study if:
 Requirement
1Pathological evidence of GBM using WHO classification criteria.
2greater than or equal to 18 years of age.
3Received maximal debulking surgery and radiotherapy with Temozolomide.
4Karnofsky scale greater than or equal to 70
5Life expectancy at least 3 months
6Participants of childbearing age must use effective contraception.
7Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms.
8Treatment start date at least 4 weeks out from surgery.
9Treatment start date at least 4 weeks out but not more than 7 weeks from last dose of adjuvant Temozolomide.
10Treatment start date at least 4 weeks out from radiation therapy.


You may not participate in this study if:
1Progressive disease.
2Actively participating in another clinical treatment trial
3Pregnant
4Significant 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)
5Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias.
6Infra-tentorial tumor
7Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
8History 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 clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.