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Post-approval Study of NovoTTF-100A in Recurrent GBM Patients

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. Identifier: NCT01756729
Recruitment Status : Terminated (Amendment of Study Protocol)
First Posted : December 27, 2012
Last Update Posted : March 2, 2016
Information provided by (Responsible Party):
NovoCure Ltd.

Brief Summary:
This is a non-randomized, concurrent control study, designed to confirm that the efficacy of the NovoTTF-100A System in patients with recurrent GBM treated in a real life settings following approval is comparable to that of BSC chemotherapy patients. The device is a portable, battery operated device that was approved for the treatment of adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM), following histologically- or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Multiforme Device: NovoTTF-100A Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Non-randomized, Concurrent Control, Open Label, Post-approval Study of NovoTTF-100A in Recurrent GBM Patient
Study Start Date : December 2012
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

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

Experimental: NovoTTF-100A (monotherapy)
Patients will be treated continuously with the NovoTTF-100A device. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.
Device: NovoTTF-100A
Multiple four-week courses of continuous NovoTTF-100A treatment.

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years from initiation of accrual ]

Secondary Outcome Measures :
  1. Change in neuro-cognitive function from baseline based on MMSE [ Time Frame: 5 years from initiation of accrual ]
  2. Genetic profiling of tumors and correlation with response to NovoTTF-100A treatment [ Time Frame: 5 years from initiation of accrual ]
  3. Adverse events severity and frequency [ Time Frame: 5 years from initiation of accrual ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 22 years of age or older
  2. Histological diagnosis of GBM (WHO grade IV)
  3. Tumor located in the supra-tentorial region of the brain
  4. Received maximal, safe, surgical resection
  5. Received maximal radiation therapy
  6. Received concomitant Temozolomide
  7. Received maintenance Temozolomide
  8. First recurrence (based on radiological or histological evidence of recurrence)
  9. Karnofsky performance score 70 or above
  10. MMSE score 25 or above
  11. Adequate amount and quality of tumor tissue from first surgical resection available for genetic profiling
  12. Women of childbearing age must be on effective contraception
  13. Signed informed consent
  14. Stable steroid dose in past 4 weeks

Exclusion Criteria:

  1. Implanted electronic medical device in the brain:

    1. Deep brain stimulator
    2. Vagus nerve stimulator
    3. Programmable shunt
  2. Skull defect without replacement
  3. Unable to comply with treatment with the NovoTTF-100A device
  4. Pregnant
  5. Prior antiangiogenic therapy (e.g., Bevacizumab/Avastin)
  6. Second or subsequent recurrence
  7. Any prior cytotoxic chemotherapy except Temozolomide
  8. Actively participating in another therapeutic clinical trial
  9. Radiological suspicion of pseudoprogression or radionecrosis
  10. Radiation therapy or surgery in the past 4 weeks
  11. Unable to comply with the study follow-up schedule
  12. Any serious co-morbidity which is expected to affect survival more adversely than GBM

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 identifier (NCT number): NCT01756729

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0111
United States, Arizona
Barrow Neurology Clinics
Phoenix, Arizona, United States, 85013
United States, California
University of California San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Keck Medical Center of USC
Los Angeles, California, United States, 90033
United States, Florida
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Kentucky
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States, 40536-0093
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, Missouri
Washington University School of Medicine, Division of Oncology
St. Louis, Missouri, United States, 63110
United States, New York
The Long Island Brain Tumor Center
Lake Success, New York, United States, 11042
United States, Pennsylvania
Geisinger Health System
Danville, Pennsylvania, United States, 17822
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75246
Sponsors and Collaborators
NovoCure Ltd.
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Principal Investigator: Herbert Engelhard, MD, PhD University of Illinois at Chicago
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Responsible Party: NovoCure Ltd. Identifier: NCT01756729    
Other Study ID Numbers: EF-19
First Posted: December 27, 2012    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by NovoCure Ltd.:
Brain tumor
Minimal toxicity
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue