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
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.

You may not participate in this study if:

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.

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.