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Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM)
This study is ongoing, but not recruiting participants.
First Received: September 20, 2006   Last Updated: May 6, 2009   History of Changes
Sponsored by: NovoCure Ltd.
Information provided by: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT00379470
  Purpose

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 Intervention Phase
Recurrent Glioblastoma Multiforme
Device: NovoTTF-100A
Phase III

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Prospective, Multi-Center Trial of NovoTTF-100A Compared to Best Standard of Care in Patients With Progressive or Recurrent GBM

Further study details as provided by NovoCure Ltd.:

Primary Outcome Measures:
  • Overall Survival

Secondary Outcome Measures:
  • Progression free survival at 6 months (PFS6)
  • Median Time to Disease Progression (TTP)
  • % 1-year survival
  • Radiological response (Macdonald criteria)
  • Quality of life assessment (EORTC QLQ-C30)
  • Adverse events severity and frequency

Enrollment: 236
Study Start Date: September 2006
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379470

  Show 25 Study Locations
Sponsors and Collaborators
NovoCure Ltd.
Investigators
Principal Investigator: Phillip Gutin, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Roger Stupp, MD University of Lausanne Hospital - Multidisciplinary Oncology Center
  More Information

Publications:
Responsible Party: NovoCure ( Mike Ambrogi )
Study ID Numbers: EF-11
Study First Received: September 20, 2006
Last Updated: May 6, 2009
ClinicalTrials.gov Identifier: NCT00379470     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NovoCure Ltd.:
Brain tumor
Treatment
Minimal toxicity
GBM
Glioblastoma
Recurrent
TTFields

Study placed in the following topic categories:
Neuroectodermal Tumors
Brain Neoplasms
Glioblastoma
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioblastoma Multiforme
Glioma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Glioblastoma
Disease Attributes
Neoplasms by Histologic Type
Astrocytoma
Neoplasms, Nerve Tissue
Recurrence
Neuroectodermal Tumors
Neoplasms
Pathologic Processes
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009