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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.
ClinicalTrials.gov Identifier:
NCT00379470
First received: September 20, 2006
Last updated: April 29, 2012
Last verified: April 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by NovoCure Ltd.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years from initiation of accrual ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival at 6 months (PFS6) [ Time Frame: 2 years from initiation of accrual ] [ Designated as safety issue: No ]
  • Median Time to Disease Progression (TTP) [ Time Frame: 2 years from initiation of accrual ] [ Designated as safety issue: No ]
  • % 1-year survival [ Time Frame: 2 years from initiation of accrual ] [ Designated as safety issue: No ]
  • Radiological response (Macdonald criteria) [ Time Frame: 2 years from initiation of accrual ] [ Designated as safety issue: No ]
  • Quality of life assessment (EORTC QLQ-C30) [ Time Frame: 2 years from initiation of accrual ] [ Designated as safety issue: No ]
  • Adverse events severity and frequency [ Time Frame: 2 years from initiation of accrual ] [ Designated as safety issue: Yes ]

Enrollment: 236
Study Start Date: September 2006
Study Completion Date: January 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT00379470     History of Changes
Other Study ID Numbers: EF-11
Study First Received: September 20, 2006
Last Updated: April 29, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014