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| 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. |
| 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.
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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.
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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.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Significant co-morbidities at baseline which would prevent maintenance temozolomide treatment:
Contacts and Locations| Contact: Mike Ambrogi | mike@novo-cure.com |
Hide Study 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. | |
| 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
| 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 |
|
Glioblastoma Multiforme Glioblastoma GBM Brain tumor Treatment |
Minimal toxicity Newly Diagnosed TTFields Tumor Treating Fields NovoCure |
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Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Neoplasms, Glandular and Epithelial |