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NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma

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ClinicalTrials.gov Identifier: NCT03232424
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
NovoCure Ltd.
Information provided by (Responsible Party):
Hackensack Meridian Health

Brief Summary:
This study is a prospective single arm trial designed to study the safety, feasibility and preliminary efficacy of a medical device, NovoTTF-200A used concomitantly with standard adjuvant treatment for newly diagnosed glioblastoma.

Condition or disease Intervention/treatment Phase
Glioblastoma, Adult Device: NovoTTF-200A Drug: Temozolomide Radiation: 3D conformal or intensity modulated radiation therapy (IMRT) Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, single arm, non-randomized, open label pilot
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Concomitant NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : July 2027
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NovoTTF-200A + Temozolomide Chemoradiation
NovoTTF-200A, concomitant with radiotherapy and temozolomide, as front-line therapy for glioblastoma
Device: NovoTTF-200A
  • Begins the day prior to radiotherapy start and continues until the end of temozolomide maintenance cycle #2 or until evidence of disease progression or unacceptable toxicity.
  • Arrays are removed immediately prior to radiotherapy and replaced immediately thereafter.
Other Name: Optune

Drug: Temozolomide

Concomitant phase:

  • 75 mg/m2 per day for 42 days concomitant with radiotherapy.
  • Begins 1 day prior to XRT start.

Maintenance phase:

  • Begins 4 weeks after concomitant phase completion (+/- 1 week).
  • Each cycle is 28 days (5 days of drug treatment followed by 23 days without).
  • Cycle 1: 150 mg/m2 once daily for the first 5 days of each treatment cycle.
  • Subsequent cycles: daily dose increased 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.

Radiation: 3D conformal or intensity modulated radiation therapy (IMRT)
Radiotherapy will commence 4 weeks after the definitive surgical procedure (+/- 1 week), to a total dose of 54.0 - 60.0 Gy, delivered in 1.8 - 2.0 Gy fractions over 6 - 7 weeks. XRT target volumes will be determined utilizing all available imaging studies that best delineate extent of disease. Fusion image registration for treatment planning will be utilized as possible. Either 3D conformal or intensity modulated radiation therapy (IMRT) will be utilized.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 24 months ]
    Safety and tolerability of combined modality treatment with radiotherapy, temozolomide and NovoTTF-200A based upon the incidence and severity of adverse events.


Secondary Outcome Measures :
  1. Overall survival time [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months ]
    Assessed from NovoTTF-200A start date to date of death of any cause. Patients will be censored at the time that they are last known to be alive (if withdrawn or lost to follow-up).

  2. Progression free survival at 6 months [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months ]
    Assessed from NovoTTF-200A start date to the date of the first observation of clinical or radiographic disease progression or death due to any cause. Patients will be censored at the time they are last known to be alive and progression free (if withdrawn or lost to follow-up).

  3. Quality of life assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30) [ Time Frame: 24 months ]
    Change from baseline at each measure will be calculated for each subscale domain and symptom scale in the questionnaire. The QLQ-C30 incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. The response scale to each question ranges from 1 (Not at All) to 4 (Very Much). For each subscale domain and symptom scale, the change from baseline will summarized as mean (SD) or median (interquartile range), as appropriate.

  4. Quality of life assessed using a European Organization for Research and Treatment of Cancer (EORTC) Brain Cancer questionnaire (BN20) [ Time Frame: 24 months ]
    Change from baseline at each measure will be calculated for each subscale domain and symptom scale in the questionnaire. The questionnaire includes 20 items assessing future uncertainty, visual disorder, motor dysfunction, communication deficit and other disease symptoms (e.g. headaches and seizures) and treatment toxicities (e.g. hair loss). The response scale to each question ranges from 1 (Not at All) to 4 (Very Much). For each subscale domain and symptom scale, the change from baseline will summarized as mean (SD) or median (interquartile range), as appropriate.



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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 GBM using WHO criteria.
  2. Age ≥ 18 years
  3. Maximal debulking surgery (at the discretion of the investigator). Biopsy alone is not exclusionary.
  4. KPS ≥ 70
  5. Life expectancy of at least 3 months.
  6. Sexually active participants must agree to the strict use of barrier contraception.
  7. Patients must be able to understand the investigational nature of the study and provide informed consent.
  8. Adequate hematologic function:

    1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    2. Platelet count ) ≥ 100 x 109/L
    3. Hemoglobin ≥ 10 g /dL
  9. Adequate liver function

    1. Total bilirubin ≤ 1.5 x ULN
    2. AST and ALT ≤ 2.5 x ULN
  10. Adequate renal function

    a. Creatinine ≤ 1.25 x ULN

  11. International normalized ratio (INR) or PT and activated partial thromboplastin time (aPTT): 1.5 x ULN (except for subjects receiving anticoagulation therapy). Use of anticoagulants is permitted as long as the INR or aPTT are within therapeutic limits (according to the medical standard of the institution).

Exclusion Criteria:

  1. Active participation in another clinical treatment trial. Concomitant protocols for data or tissue collection without intervention are permitted.
  2. Any prior treatment for GBM aside from surgery, including carmustine wafers.
  3. Women who are pregnant or nursing.
  4. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation, NovoTTF-200A device use or interfere with interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial. This includes but not limited to:

    1. Patients with inadequately healed surgical incisions or other dermatologic scalp toxicity at baseline (grade 2 or higher, as defined in Section VIII) upon which transducer leads may require placement.
    2. Known HIV or other immunosuppressive disease, chronic hepatitis B or hepatitis C
    3. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.
  5. Implanted pacemaker, programmable shunt, cardiac defibrillator, deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias.
  6. Infratentorial glioblastoma.
  7. Past hypersensitivity reaction to temozolomide or DTIC.
  8. Psychiatric illness that compromises the informed consent process, at the discretion of the investigator.
  9. Inability or unwillingness to return for required visits.
  10. Previous cytotoxic therapy within the last 5 years.
  11. Inability to begin temozolomide concomitant to radiation therapy, for reasons 4 or 7 above.

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): NCT03232424


Contacts
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Contact: Lori Cappello 551-996-5078 Lori.Cappello@HackensackMeridian.org

Locations
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United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Lori Cappello    551-996-5098    Lori.Cappello@HackensackMeridian.org   
Principal Investigator: Samuel A Goldlust, MD         
Sub-Investigator: Samuel Singer, MD         
Sub-Investigator: Kangmin D Lee, MD         
Sub-Investigator: Hooman Azmi Ghadimi, MD         
Sub-Investigator: Anthony C Ingenito, MD         
Sub-Investigator: Brett E Lewis, MD, PhD         
Sub-Investigator: George J Kaptain, MD         
Sponsors and Collaborators
Hackensack Meridian Health
NovoCure Ltd.

Publications:
Polk C. Therapeutic applications of low-frequency sinusoidal and pulsed electric and magnetic fields. In: Bronzino JD ed. The biomedical engineering handbook. Connecticut: CRC Press, 1995:1404-1416.
Elson E. Biologic Effects of radiofrequency and microwave fields: in vivo and in vitro experimental results. In: Bronzino JD ed. The biomedical engineering handbook. Connecticut: CRC Press, 1995:1417-1423.
Chou CK. Radiofrequency hyperthermia in cancer therapy. In: Bronzino JD ed. The biomedical engineering handbook. Connecticut: CRC Press, 1995:1424-1430.
Stupp R, Wong E, Scott C et al. Interim analysis of the EF-14 trial: a prospective, multi-center trial of NovoTTF-100A together with temozolomide compared to temozolomide alone in patients with newly diagnosed GBM. Neuro Oncol 2014;16(suppl 5):v167.
Giladi M, Zielinska-Chomej K, Tichon A et al. The effect of alternating electric fields (TTFields) on inhibition of repair of DNA damage induced by ionizing radiation and sensitization of glioma and non-small cell lung cancer cells to radiation. J Clin Oncol 2014;32(suppl;abstr e22239).
Zielinska-Chomej K, Grozman V, Tu J, Viktorsson K, Lewensohn R. Analysis of combination of tumor treating fields (TTFields) with radiotherapy in non-small cell lung cancer. Neuro Oncol 2013;15(suppl 3):ET-033.

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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT03232424     History of Changes
Other Study ID Numbers: Pro2017-0087
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
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