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TTFields Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780569
Recruitment Status : Active, not recruiting
First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.

Brief Summary:
The study is a prospective, single arm open label study, designed to test the to evaluate the tolerability and safety outcome of newly diagnosed GBM patients treated with NovoTTF-200A concomitant to Radiotherapy/Temozolomide followed by Temozolomide. The device is a 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 or disease Intervention/treatment Phase
Glioblastoma Multiforme Device: NovoTTF-200A Radiation: Radiotherapy Drug: Temozolomide Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Trial of NovoTTF-200A Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM
Actual Study Start Date : April 27, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NovoTTF-200A/Radiotherapy/Temozolomide
Patients will receive multiple 1 month courses of continuous NovoTTF-200A treatment together with standard Radiotherapy/Temozolomide followed by maintenance Temozolomide.
Device: NovoTTF-200A
Patients receive continuous TTFields treatment using the NovoTTF-200A device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the scalp. The treatment enables the patient to maintain regular daily routine.

Radiation: Radiotherapy
60Gy given in 30 2Gy fractions concomitant to temozolomide

Drug: Temozolomide

Temozolomide(TMZ) will be administered at 75 mg/m^2 concomitant to radiotherapy(RT) and NovoTTF-200A.

Maintenance treatment is to begin about 4 weeks after the end of TMZ/RT/NovoTTF-200A. TMZ is administered at the conventional dosing regimen for 5 days, every 28 days (i.e. 5 days of therapy, 23 days of rest). Cycle 1 is to be given at a dose of 150 mg/m^2 p.o. daily x 5 days, dose to be escalated to 200 mg/m^2 in the absence of toxicity.





Primary Outcome Measures :
  1. Safety of concomitant Radiotherapy/Temozolomide with NovoTTF-200A: The incidence of Radiotherapy treatment delays during concomitant Radiotherapy/Temozolomide/NovoTTF-200A will be documented including severity and relationship to NovoTTF-200A. [ Time Frame: 2 years ]
    The incidence of Radiotherapy treatment delays during concomitant Radiotherapy/Temozolomide/NovoTTF-200A will be documented including severity and relationship to NovoTTF-200A.


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 2 years ]
  2. Overall survival [ Time Frame: 2 years ]
  3. Adverse events, severity and frequency [ Time Frame: 2 years ]
    Safety of NovoTTF-200A treatment based on the incidence and severity of adverse events and toxicities.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed diagnosis of GBM according to WHO classification criteria.
  2. Supratentorial tumor location
  3. Age ≥ 18 years
  4. Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection and biopsy-only patients are all acceptable)
  5. Planned standard adjuvant chemoradiotherapy of approx. 60 Gy of Radiotherapy (RT), or biologically equivalent dose, according to local practice, and concomitant Temozolomide (TMZ) chemotherapy (75mg/m^2 daily). Any other cytotoxic or biologic anti-tumor therapy received prior to enrollment will be considered an exclusion.
  6. Planned treatment with adjuvant/maintenance TMZ (150-200 mg/m^2 daily x 5 d, q28 days)
  7. Karnofsky performance status ≥ 70
  8. Life expectancy ≥ 3 months
  9. Participants of childbearing age must use effective contraception.
  10. All patients must sign written informed consent.
  11. NovoTTF-200A treatment start date at least 2 weeks out from brain surgery.
  12. NovoTTF-200A treatment start prior to or at the beginning of RT/TMZ
  13. Stable or decreasing dose of corticosteroids for the last 7 days prior to enrollment, if applicable.

Exclusion Criteria:

  1. Participation in another clinical treatment trial
  2. Pregnancy or breast feeding
  3. Significant co-morbidities at baseline which would preclude TMZ treatment
  4. Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
  5. Infra-tentorial tumor location
  6. Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
  7. History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC.
  8. Known allergies to medical adhesives or gel

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780569


Locations
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Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
NovoCure Ltd.

Publications:
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Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT03780569     History of Changes
Other Study ID Numbers: ICH-1
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NovoCure Ltd.:
GBM
TTFields
Tumor Treating Fields
Glioblastoma
Glioblastoma Multiforme
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents