Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00916409 : Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)
PhasePhase 3
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

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):

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

2. Any additional treatments received prior to enrollment will be considered an
exclusion.

3. 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.

Exclusion Criteria:

1. Progressive disease (according to MacDonald Criteria). If pseudoprogression is
suspected, additional imaging studies must be performed to rule out true progression.

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 x 103/?L)

2. Neutropenia (absolute neutrophil count < 1.5 x 103/?L)

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 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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00916409      |      Link to official Clinicaltrials.gov listing
Locations



Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2018 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740