Clinical Trial Details
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NCT02441322 : Evaluating Therapeutic Response to Novo-TTF
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Newly diagnosed or recurrent GBMs

- Received maximal debulking surgery and radiotherapy concomitant with Temozolomide

- Patients may enroll in the study if received Gliadel wafers before entering the trial.

- Minimal dose for concomitant radiotherapy is 45 Gy

- Karnofsky scale of 60 or greater

- Life expectancy at least 3 months

- Must sign written informed consent

- Treatment start date at least 4 weeks out from surgery

- Measurable enhancing neoplasm on post contrast T1 weighted images and/or non enhancing
FLAIR signal abnormality

Exclusion Criteria:

- Actively participating in another clinical treatment trial

- Pregnant

- Significant co-morbidities at baseline which would prevent maintenance Temozolomide

1. Thrombocytopenia (platelet count less than 100 x 1000 per microlitre)

2. Neutropenia (absolute neutrophil count less than 1.5 x 1000 per microlitre)

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

5. Total bilirubin upper limit of normal

6. Significant renal impairment (serum creatinine greater than 1.7 mg/dL)

- Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other
implanted electronic devices in the brain, or documented clinically significant

- Infra-tentorial tumor

- 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.
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