Trial record 1 of 1 for:    NovoCure EF-14
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Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.
ClinicalTrials.gov Identifier:
NCT00916409
First received: June 5, 2009
Last updated: May 19, 2015
Last verified: May 2015
  Purpose

The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.


Condition Intervention Phase
Glioblastoma Multiforme
Device: NovoTTF-100A device
Drug: Temozolomide
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 Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM.

Resource links provided by NLM:


Further study details as provided by NovoCure Ltd.:

Primary Outcome Measures:
  • Progression Free Survival (PFS) time [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: June 2009
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NovoTTF-100A device in combination with Temozolomide
patients will be treated continuously with the NovoTTF-100A device, in addition to Temozolomide. 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 device
patients will be treated continuously with the NovoTTF-100A device, in addition to Temozolomide. 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.
Active Comparator: Temozolomide alone, as the best known standard of care
Patients will be treated with Temozolomide, as the best known standard of care for Glioblastoma Multiforme patients.
Drug: Temozolomide

maintenance Temozolomide will be administered according to the approved dosing scheme as follows: Maintenance Phase Cycle 1: Four weeks after completing the Temozolomide + Radiotherapy phase, Temozolomide is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.

Cycles 2-6: At the start of Cycle 2, the dose is escalated to 200 mg/m2, if the CTC non-hematologic toxicity for Cycle 1 is Grade ≤2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/L, and the platelet count is ≥ 100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.


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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:

  1. Pathological evidence of GBM using WHO classification criteria.
  2. > 18 years of age.
  3. Received maximal debulking surgery and radiotherapy concomitant with Temozolomide (45-70Gy):

    1. Patients may enroll in the study if received Gliadel wafers before entering the trial
    2. Any additional treatments received prior to enrollment will be considered an exclusion.
    3. Minimal dose for concomitant radiotherapy is 45 Gy
  4. Karnofsky scale ≥ 70
  5. Life expectancy at least 3 months
  6. Participants of childbearing age must use effective contraception.
  7. All patients must sign written informed consent.
  8. Treatment start date at least 4 weeks out from surgery.
  9. Treatment start date at least 4 weeks out but not more than 7 weeks from the later of last dose of concomitant Temozolomide or radiotherapy.

Exclusion Criteria:

  1. Progressive disease (according to MacDonald Criteria). If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
  2. Actively participating in another clinical treatment trial
  3. Pregnant
  4. Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:

    1. Thrombocytopenia (platelet count < 100 x 103/μL)
    2. Neutropenia (absolute neutrophil count < 1.5 x 103/μL)
    3. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
    4. Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
    5. Total bilirubin > upper limit of normal
    6. Significant renal impairment (serum creatinine > 1.7 mg/dL)
  5. Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
  6. Infra-tentorial tumor
  7. Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
  8. History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC.
  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: NCT00916409

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3410
United States, Arizona
Barrow Neurology Clinics
Phoenix, Arizona, United States, 85013
United States, California
City of Hope
Duarte, California, United States, 91010-3000
University of California San Diego Moores Cancer Center (UCSD)
La Jolla, California, United States, 92093
University of Southern California (USC)
Los Angeles, California, United States, 90033
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Florida
UF Health Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Illinois at Chicago (UIC)
Chicago, Illinois, United States, 60612
United States, Kentucky
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States, 40536-0093
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Maine
Maine Medical Center
Scarborough, Maine, United States, 04074
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University School of Medicine, Division of Oncology
St. Louis, Missouri, United States, 63110
United States, New Jersey
New Jersey Neuroscience Center - JFK Medical Center
Edison, New Jersey, United States, 08818
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Mount Sinai Medical Center, Department of Neurosurgery
New York, New York, United States, 10029
Weill Cornell Medical College
New York, New York, United States, 10021
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
The Ohio State University Arthur G. James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Geisinger Health System
Danville, Pennsylvania, United States, 17822
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Baylor
Dallas, Texas, United States, 75246
UT Southwestern Medical Center
Dallas, Texas, United States, 75235-8808
Methodist Neurological Institute
Houston, Texas, United States, 77030
The University of Texas Health Science Center at Houston (UTHSC)
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
Scott and White Healthcare
Temple, Texas, United States, 76508
Memorial Hermann The Woodlands
The Woodlands, Texas, United States, 77380
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States, 98195
Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
Austria
University Hospital Graz
Graz, Austria
Medical University of Vienna
Vienna, Austria
SMZ-Süd/Kaiser-Franz-Josef-Spital
Vienna, Austria
Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Juravinski Cancer Centre
Hamilton,, Ontario, Canada, L8V5C2
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
McGill - Gerald Bronfman Centre for Clinical Research in Oncology -
Montreal, Quebec, Canada, H3T 1E2
Montreal Neurological Institute
Montreal, Quebec, Canada, H3A 2B4
Notre-Dame Hospital (CHUM)
Montreal, Quebec, Canada, H2L 4 M1
(CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie
Sherbrooke, Quebec, Canada, J1H 5N4
Czech Republic
Na Homolce Hospital
Prague, Czech Republic
France
CHU Amiens Sud-Salouel
Amiens, France
CHU Angers
Angers, France
Hôpital Saint André Centre Hospitalier Universitaire (CHU) des Hôpitaux de Bordeaux
Bordeaux, France
Hospital of Neurology Pierre Wertheimer
Lyon, France
Group Hospitals Pitie-Salpetriere
Paris, France
Centre Hospitalo-Universitaire de Toulouse Purpan
Toulouse, France
Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Medical University Heidelberg
Heidelberg, Germany
University Hospital of Schleswig-Holstein
Kiel, Germany
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Italy
Az. Ospedaliero-Universitaria - Ospedali Riuniti
Ancona, Italy
Ospedale Lecco
Lecco, Italy
C. Besta Neurological Institute
Milan, Italy
Foundation Hospital Greater Policlinico
Milan, Italy
Istituti Fisioterapici Ospitalieri - Istituto Nazionale dei Tumori Regina Elena
Rome, Italy
Korea, Republic of
Asan Medical Center
Asan, Korea, Republic of
Yeungnam University Hospital
Daegu, Korea, Republic of
Chungnam National University Hospital (CNUH)
Daejeon, Korea, Republic of
Yonsei University Severance Hospital (YUHS)
Seoul, Korea, Republic of
Seoul National University Bundang Hospital (SNUBH)
Seoul, Korea, Republic of
Seoul National University Hospital (SNUH)
Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital (CMC Seoul)
Seoul, Korea, Republic of
Samsung Medical Center (SMC)
Seoul, Korea, Republic of
Ajou University Hospital (AUH)
Suwon, Korea, Republic of
Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari de Bellvitge-ICO Duran i Reynals
Barcelona, Spain
Hospital 12 de Octubre, Servicio de Oncología Médica
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Fundacion Jimenes Diaz
Madrid, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Sweden
Karolinska Institute
Stockholm, Sweden
Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland
UniversitätsSpital Zürich
Zurich, Switzerland
Sponsors and Collaborators
NovoCure Ltd.
Investigators
Study Director: Roger Stupp, MD University Hospital, Zürich
Study Director: Philip H. Gutin, MD Memorial Sloan Kettering Cancer Center
Study Director: Eric T. Wong, MD Beth Israel Deaconess Medical Center
Study Director: Herbert H. Engelhard, MD, PhD University of Illinois at Chicago
Study Director: Manfred Westphal, Prof. MD Universitätsklinikum Hamburg-Eppendorf
  More Information

Publications:
Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT00916409     History of Changes
Other Study ID Numbers: EF-14
Study First Received: June 5, 2009
Last Updated: May 19, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by NovoCure Ltd.:
Glioblastoma Multiforme
Glioblastoma
GBM
Brain tumor
Treatment
Minimal toxicity
Newly Diagnosed
TTFields
Tumor Treating Fields
NovoCure

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
Dacarbazine
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 30, 2015