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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by NovoCure Ltd.
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.
ClinicalTrials.gov Identifier:
NCT01756729
First received: December 20, 2012
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Recurrent Glioblastoma Multiforme
Device: NovoTTF-100A
Phase 4

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

Resource links provided by NLM:


Further study details as provided by NovoCure Ltd.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 5 years from initiation of accrual ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in neuro-cognitive function from baseline based on MMSE [ Time Frame: 5 years from initiation of accrual ] [ Designated as safety issue: No ]
  • Genetic profiling of tumors and correlation with response to NovoTTF-100A treatment [ Time Frame: 5 years from initiation of accrual ] [ Designated as safety issue: No ]
  • Adverse events severity and frequency [ Time Frame: 5 years from initiation of accrual ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 486
Study Start Date: December 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01756729

Contacts
Contact: Ghazala Kabani patientinfo@novocure.com

Locations
United States, California
University of California San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Angel Nguyen    858-822-0201    anguyen85@ucsd.edu   
Principal Investigator: Santosh Kesari, M.D., PhD.         
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Herbert Engelhard, MD, PhD    312-282-5821    hengel@uic.edu   
Principal Investigator: Herbert Engelhard, MD, PhD         
United States, Kentucky
University of Kentucky, Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Tonya Gardner    859-323-0532    tonya.gardner@uky.edu   
Principal Investigator: John Villano, MD, PhD         
United States, Missouri
Washington University School of Medicine, Division of Oncology Recruiting
St. Louis, Missouri, United States, 63110
Contact: Abigail S Gwinn    314-747-4678    AGWINN@DOM.wustl.edu   
Principal Investigator: David Tran, MD, PhD         
United States, New York
The Long Island Brain Tumor Center Recruiting
Lake Success, New York, United States, 11042
Contact: Kimberly Prabhu       kprabhu@nspc.com   
Principal Investigator: Jai Grewal, M.D         
Sub-Investigator: Paul Duic, M.D         
Sponsors and Collaborators
NovoCure Ltd.
Investigators
Principal Investigator: Herbert Engelhard, MD, PhD University of Illinois at Chicago
  More Information

Publications:
Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT01756729     History of Changes
Other Study ID Numbers: EF-19
Study First Received: December 20, 2012
Last Updated: September 12, 2013
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
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on October 23, 2014