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Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00379470
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : May 1, 2012
Information provided by (Responsible Party):
NovoCure Ltd.

Brief Summary:
The study is a randomized, controlled trial, designed to test the efficacy and safety of a new medical device, the NovoTTF-100A. The device is an experimental, portable, battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme (GBM) using alternating electric fields (termed TTFields).

Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Multiforme Device: NovoTTF-100A Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center Trial of NovoTTF-100A Compared to Best Standard of Care in Patients With Progressive or Recurrent GBM
Study Start Date : September 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Best Standard of Care
Patients randomized to the BSC group will be treated with one chemotherapy according to the BSC practiced at each center.
Device: NovoTTF-100A
multiple four-week courses of continuous NovoTTF-100A treatment

Experimental: NovoTTF-100A Device: NovoTTF-100A
multiple four-week courses of continuous NovoTTF-100A treatment

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years from initiation of accrual ]

Secondary Outcome Measures :
  1. Progression free survival at 6 months (PFS6) [ Time Frame: 2 years from initiation of accrual ]
  2. Median Time to Disease Progression (TTP) [ Time Frame: 2 years from initiation of accrual ]
  3. % 1-year survival [ Time Frame: 2 years from initiation of accrual ]
  4. Radiological response (Macdonald criteria) [ Time Frame: 2 years from initiation of accrual ]
  5. Quality of life assessment (EORTC QLQ-C30) [ Time Frame: 2 years from initiation of accrual ]
  6. Adverse events severity and frequency [ Time Frame: 2 years from initiation of accrual ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pathological evidence of GBM using WHO classification criteria.
  • > 18 years of age.
  • Not a candidate for further radiotherapy or additional resection of residual tumor.
  • Patients with disease progression (by Macdonald criteria i.e., > 25% or new lesion) documented by CT or MRI within 4 weeks prior to enrollment
  • Karnofsky scale ≥ 70
  • Life expectancy at least 3 months
  • Participants of childbearing age must use effective contraception.
  • All patients must sign written informed consent.

Exclusion Criteria:

  • Actively participating in another clinical treatment trial
  • Within 4 weeks from surgery for recurrence
  • Within 4 weeks from any prior chemotherapy.
  • Within 4 weeks from radiation therapy
  • Pregnant
  • Significant co-morbidities (within 4 weeks prior to enrollment):

    1. Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
    2. Total bilirubin > upper limit of normal
    3. Significant renal impairment (serum creatinine > 1.7 mg/dL)
    4. Coagulopathy (as evidenced by PT or APTT >1.5 times control in patients not undergoing anticoagulation)
    5. Thrombocytopenia (platelet count < 100 x 103/μL)
    6. Neutropenia (absolute neutrophil count < 1 x 103/μL)
    7. Anemia (Hb < 10 g/L)
    8. Severe acute infection
  • Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias.
  • Infra-tentorial tumor
  • Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379470

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Sponsors and Collaborators
NovoCure Ltd.
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Principal Investigator: Phillip Gutin, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Roger Stupp, MD University of Lausanne Hospital - Multidisciplinary Oncology Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT00379470    
Other Study ID Numbers: EF-11
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012
Keywords provided by NovoCure Ltd.:
Brain tumor
Minimal toxicity
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue