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Spots Global Cancer Trial Database for Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)

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Trial Identification

Brief Title: Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)

Official Title: A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM.

Study ID: NCT00916409

Study Description

Brief Summary: 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.

Detailed Description: PAST CLINICAL EXPERIENCE: The effect of the electric fields generated by the NovoTTF-100A device (TTFields, TTF) has been tested in a large prospective, randomized trial, in recurrent GBM. The outcome of subjects treated with the NovoTTF-100A device was compared to those treated with an effective best standard of care chemotherapy (including bevacizumab). NovoTTF-100A subjects had comparable overall survival to subjects receiving the best available chemotherapy in the US today. Similar results showing comparability of NovoTTF-100A to BSC chemotherapy were seen in all secondary endpoints. Recurrent GBM patients treated with the NovoTTF-100A device in this trial experienced fewer side effects in general, significantly fewer treatment related side effects, and significantly lower gastrointestinal, hematological and infectious adverse events compared to controls. The only device-related adverse events seen were a mild to moderate skin irritation beneath the device electrodes. Finally, quality of life measures were better in NovoTTF-100A subjects as a group when compared to subjects receiving effective best standard of care chemotherapy. In a small scale pilot trial in newly diagnosed GBM patients, the treatment was well tolerated and suggested that NovoTTF-100A may improve time to disease progression and overall survival of newly diagnosed GBM patients. Although the number of patients in the pilot trial was small, The FDA has determined that the data gathered so far warrant testing of NovoTTF-100A treatment as a possible therapy for patients with newly diagnosed GBM. DESCRIPTION OF THE TRIAL: All patients included in this trial are newly diagnosed GBM patients who underwent a biopsy or surgery (with or without Gliadel wafers), followed by radiation therapy in combination with Temozolomide chemotherapy. In addition, all patients must meet all eligibility criteria. Eligible patients will be randomly assigned to one of two groups: 1. Treatment with the NovoTTF-100A device in combination with Temozolomide chemotherapy. 2. Treatment with Temozolomide alone, as the best known standard of care. Patients will be randomized at a 2:1 ratio (2 of every three patients who participate in the trial will be treated with the NovoTTF-100A device). Baseline tests will be performed in patients enrolled in both arms, including specific genetic tests done using tumor samples obtained during their initial surgery. If assigned to the NovoTTF-100A in combination with Temozolomide group, the patients will be treated continuously with the device until second progression. They will also receive temozolomide and possibly a second line treatment that can be one of the following: re-operation, local radiotherapy (gamma-knife), a second line of chemotherapy or a combination of the above. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. Electrode array placement will require shaving of the scalp before and frequently during the treatment. After an initial short visit to the clinic for training and monitoring, patients will be released to continue treatment at home where they can maintain their regular daily routine. During the trial, regardless of which treatment group the patient was assigned to, he or she will need to return once every month to the clinic where an examination by a physician and a routine laboratory examinations will be done. These routine visits will continue for as long as the patient's disease is not progressing for the second time under the study treatment. If such occurs, patients will need to return once per month for two more months to the clinic for similar follow up examinations. During the visits to the clinic patients will be examined physically and neurologically. Additionally, routine blood tests will be performed. A routine MRI of the head will be performed at baseline and every second month thereafter, until second progression. After this follow up plan, patients will be contacted once per month by telephone to answer basic questions about their health status. SCIENTIFIC BACKGROUND: Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field. These forces cause movement and rotation of electrically charged biological building blocks, much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet. Electric fields can also cause muscles to twitch and if strong enough may heat tissues. TTFields are alternating electric fields of low intensity. This means that they change their direction repetitively many times a second. Since they change direction very rapidly (200 thousand times a second), they do not cause muscles to twitch, nor do they have any effects on other electrically activated tissues in the body (brain, nerves and heart). Since the intensities of TTFields in the body are very low, they do not cause heating. The breakthrough finding made by NovoCure was that finely tuned alternating fields of very low intensity, now termed TTFields (Tumor Treating Fields), cause a significant slowing in the growth of cancer cells. Due to the unique geometric shape of cancer cells when they are multiplying, TTFields cause the building blocks of these cells to move and pile up in such a way that the cells physically explode. In addition, cancer cells also contain miniature building blocks which act as tiny motors in moving essential parts of the cells from place to place. TTFields cause these tiny motors to fall apart since they have a special type of electric charge. As a result of these two effects, cancer tumor growth is slowed and can even reverse after continuous exposure to TTFields. Other cells in the body (normal healthy tissues) are affected much less than cancer cells since they multiply at a much slower rate if at all. In addition TTFields can be directed to a certain part of the body, leaving sensitive areas out of their reach. In conclusion, TTField hold the promise of serving as a brand new cancer treatment with very few side effects and promising affectivity in slowing or reversing this disease.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama at Birmingham, Birmingham, Alabama, United States

Barrow Neurology Clinics, Phoenix, Arizona, United States

City of Hope, Duarte, California, United States

University of California San Diego Moores Cancer Center (UCSD), La Jolla, California, United States

University of Southern California (USC), Los Angeles, California, United States

University of Colorado Denver, Aurora, Colorado, United States

UF Health Cancer Center at Orlando Health, Orlando, Florida, United States

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

Emory University, Winship Cancer Institute, Atlanta, Georgia, United States

University of Illinois at Chicago (UIC), Chicago, Illinois, United States

University of Kentucky, Markey Cancer Center, Lexington, Kentucky, United States

Norton Cancer Institute, Louisville, Kentucky, United States

Maine Medical Center, Scarborough, Maine, United States

The Johns Hopkins Hospital, Baltimore, Maryland, United States

Tufts Medical Center, Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Lahey Clinic Medical Center, Burlington, Massachusetts, United States

Henry Ford Health System, Detroit, Michigan, United States

Washington University School of Medicine, Division of Oncology, St. Louis, Missouri, United States

New Jersey Neuroscience Center - JFK Medical Center, Edison, New Jersey, United States

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States

Weill Cornell Medical College, New York, New York, United States

Mount Sinai Medical Center, Department of Neurosurgery, New York, New York, United States

Columbia University Medical Center, New York, New York, United States

University of North Carolina, Chapel Hill, North Carolina, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States

The Ohio State University Arthur G. James Cancer Hospital and Solove Research Institute, Columbus, Ohio, United States

Geisinger Health System, Danville, Pennsylvania, United States

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Pennsylvania Hospital, Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania, United States

UT Southwestern Medical Center, Dallas, Texas, United States

Baylor, Dallas, Texas, United States

Methodist Hospital, Houston, Texas, United States

Methodist Neurological Institute, Houston, Texas, United States

The University of Texas Health Science Center at Houston (UTHSC), Houston, Texas, United States

Scott and White Healthcare, Temple, Texas, United States

Memorial Hermann The Woodlands, The Woodlands, Texas, United States

University of Virginia Health System, Charlottesville, Virginia, United States

Swedish Neuroscience Institute, Seattle, Washington, United States

University of Washington/Seattle Cancer Care Alliance, Seattle, Washington, United States

University Hospital Graz, Graz, , Austria

Medical University of Vienna, Vienna, , Austria

SMZ-Süd/Kaiser-Franz-Josef-Spital, Vienna, , Austria

Tom Baker Cancer Center, Calgary, Alberta, Canada

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Juravinski Cancer Centre, Hamilton,, Ontario, Canada

The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada

Notre-Dame Hospital (CHUM), Montreal, Quebec, Canada

Montreal Neurological Institute, Montreal, Quebec, Canada

McGill - Gerald Bronfman Centre for Clinical Research in Oncology -, Montreal, Quebec, Canada

(CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie, Sherbrooke, Quebec, Canada

Na Homolce Hospital, Prague, , Czech Republic

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

University Medical Center Hamburg-Eppendorf, Hamburg, , Germany

Medical University Heidelberg, Heidelberg, , Germany

University Hospital of Schleswig-Holstein, Kiel, , Germany

Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel

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

Asan Medical Center, Asan, , Korea, Republic of

Yeungnam University Hospital, Daegu, , Korea, Republic of

Chungnam National University Hospital (CNUH), Daejeon, , Korea, Republic of

Samsung Medical Center (SMC), 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

Yonsei University Severance Hospital (YUHS), Seoul, , Korea, Republic of

Ajou University Hospital (AUH), Suwon, , Korea, Republic of

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

Fundacion Jimenes Diaz, Madrid, , Spain

Hospital 12 de Octubre, Servicio de Oncología Médica, Madrid, , Spain

Hospital Clinico San Carlos, Madrid, , Spain

Hospital Universitario Ramon y Cajal, Madrid, , Spain

Clínica Universidad de Navarra, Pamplona, , Spain

Karolinska Institute, Stockholm, , Sweden

Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, , Switzerland

UniversitätsSpital Zürich, Zurich, , Switzerland

Contact Details

Name: Roger Stupp, MD

Affiliation: University Hospital, Zürich

Role: STUDY_DIRECTOR

Name: Philip H. Gutin, MD

Affiliation: Memorial Sloan Kettering Cancer Center

Role: STUDY_DIRECTOR

Name: Eric T. Wong, MD

Affiliation: Beth Israel Deaconess Medical Center

Role: STUDY_DIRECTOR

Name: Herbert H. Engelhard, MD, PhD

Affiliation: University of Illinois at Chicago

Role: STUDY_DIRECTOR

Name: Manfred Westphal, Prof. MD

Affiliation: Universitätsklinikum Hamburg-Eppendorf

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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