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Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)
This study is currently recruiting participants.
Verified by NovoCure Ltd., November 2009
First Received: June 5, 2009   Last Updated: November 15, 2009   History of Changes
Sponsor: NovoCure Ltd.
Information provided by: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT00916409
  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) to the region of the malignant tumor, by means of surface, insulated electrodes.


Condition Intervention Phase
Glioblastoma Multiforme
Device: NovoTTF-100A device
Drug: Temozolomide
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Progression free survival at 6 months (PFS6) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 1% and 2-year survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Radiological response (Macdonald criteria) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Quality of life assessment (EORTC QLQ-C30) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Adverse events severity and frequency [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 283
Study Start Date: June 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
NovoTTF-100A device in combination with Temozolomide: Experimental
patients will be treated continuously with the NovoTTF-100A device, in addition to Temozolomide. NovoTTF-100A treatment will consist of wearing four electrically insulated electrodes 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 electrodes on the head. The treatment enables the patient to maintain regular daily routine.
Temozolomide alone, as the best known standard of care: Active Comparator
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.


  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
  • Received maximal debulking surgery and radiotherapy with Temozolomide
  • Karnofsky scale ≥ 70
  • Life expectancy at least 3 months
  • Participants of childbearing age must use effective contraception
  • All patients must sign written informed consent
  • Treatment start date at least 4 weeks out from surgery
  • Treatment start date at least 4 weeks out but not more than 7 weeks from last dose of adjuvant Temozolomide
  • Treatment start date at least 4 weeks out from radiation therapy

Exclusion Criteria:

  • Progressive disease (according to MacDonald Criteria)
  • Actively participating in another clinical treatment trial
  • Pregnant
  • 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)
  • 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)
  • History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916409

Contacts
Contact: Mike Ambrogi mike@novo-cure.com

  Hide Study Locations
Locations
United States, California
University of Southern California Not yet recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Thomas C. Chen, M.D., PhD.            
University of California San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Alexander Hu     858-822-5377     alhu@ucsd.edu    
Principal Investigator: William Read, M.D.            
United States, Florida
MD Anderson Cancer Center Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Casey Kulscar, RN     321-841-4347     Casey.Kulscar@orlandohealth.com    
Principal Investigator: Nicholas G. Avgeropoulos, M.D.            
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Karriem S. Watson, M.D.     312-355-0334     kswatson@uic.edu    
Principal Investigator: Herbert H. Engelhard, M.D., PhD.            
United States, Maine
Maine Medical Center Recruiting
Scarborough, Maine, United States, 04074
Contact: Debbie Cushing, R.N.     207-885-4438     cushid@mmc.org    
Principal Investigator: Rajiv Desai, M.D.            
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Eric T. Wong, M.D.            
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Priya Shantilal     617-636-2883     pshantilal@tuftsmedicalcenter.org    
Principal Investigator: Jay-Jiguang Zhu, MD            
United States, New Jersey
New Jersey Neuroscience Center - JFK Medical Center Recruiting
Edison, New Jersey, United States, 08818
Contact: Charles Porbeni     732-321-7000 ext 68897        
Principal Investigator: Joseph C. Landolfi, D.O.            
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Euphael Henry, MD     212-746-2438     euh2002@med.cornell.edu    
Principal Investigator: Susan Pannullo, M.D.            
United States, Ohio
Cleveland Clinic Taussig Cancer Center Not yet recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Robert J. Weil, M.D.            
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Teresa Donegan         donegante@upmc.edu    
Principal Investigator: Frank S. Lieberman, M.D.            
Geisinger Health System Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Angela Whitmire, RN     570-214-9603     awhitmire@geisinger.edu    
Principal Investigator: Steven A. Toms, M.D.            
United States, Texas
Baylor Recruiting
Dallas, Texas, United States, 75246
Contact: Stephanie Peschka, RN     214-820-8690     stephape@BaylorHealth.edu    
Principal Investigator: Karen L. Fink, M.D., PhD.            
Austria
University Hospital Graz Recruiting
Graz, Austria
Contact: Margarita Klein     43-664-843-8849     margarita.klein@medunigraz.at    
Principal Investigator: Franz Payer, M.D.            
France
Group Hospitals Pitie-Salpetriere Recruiting
Paris, France
Contact: Louise Anemet     01 42 16 04 04     louise.anemet@psl.aphp.fr    
Principal Investigator: Sophie Tailibert, M.D.            
Hospital of Neurology Lyon - University Claude Bernard Recruiting
Lyon, France
Contact: Martine Lionnet     +33 472 355460     martine.lionnet@chu-lyon.fr    
Principal Investigator: Jermone Honnorat, M.D.            
Centre Hospitalo-Universitaire de Toulouse Purpan Not yet recruiting
Toulouse, France
Principal Investigator: Alexandra Benouaich-Amiel, MD            
Germany
University Hospital of Schleswig-Holstein Recruiting
Kiel, Germany
Contact: Maximillian Mehdorn, M.D, PhD.     0049 431 597 4800     mehdorn@nch.uni-kiel.de    
Principal Investigator: Maximilian Mehdorn, M.D.            
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany
Contact: Dr. Oliver Heese, M.D.     49 40 741035316     heese@uke.uni-hamburg.de    
Principal Investigator: Manfred Westphal, M.D.            
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Carmit Ben Harosh     972 52 426 2245     carmitbh@tasmc.health.gov.il    
Principal Investigator: Andrew Kanner, M.D.            
Italy
C. Besta Neurological Institute Recruiting
Milan, Italy
Contact: Paola Gaviani, M.D.     0039 02 2394 2440     paola.gaviani@istituto-besta.it    
Principal Investigator: Andrea Salmaggi, M.D.            
Foundation Hospital Greater Policlinico Recruiting
Milan, Italy
Contact: Manuela Caroli, M.D.     0039 02 55035528     man.caroli@tin.it    
Principal Investigator: Lorenzo Bello, M.D.            
Sponsors and Collaborators
NovoCure Ltd.
Investigators
Study Director: Roger Stupp, MD University of Lausanne Hospital - Multidisciplinary Oncology Center
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
Study Director: Manfred Westphal, Prof. MD Universitätsklinikum Hamburg-Eppendorf
Study Director: Robert J. Weil, MD The Cleveland Clinic
  More Information

Publications:
Responsible Party: NovoCure Ltd. ( Mike Ambrogi )
Study ID Numbers: EF-14
Study First Received: June 5, 2009
Last Updated: November 15, 2009
ClinicalTrials.gov Identifier: NCT00916409     History of Changes
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
Neoplasms by Histologic Type
Dacarbazine
Molecular Mechanisms of Pharmacological Action
Astrocytoma
Antineoplastic Agents
Neoplasms, Nerve Tissue
Temozolomide
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009