Glioblastoma, AdultPhase 1NCT03232424
NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma
A Phase 1 study testing NovoTTF-200A, Temozolomide and 3D conformal or intensity modulated radiation therapy (IMRT) in people with Glioblastoma, Adult, run by Hackensack Meridian Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Adult
- What is being tested?
- NovoTTF-200A, Temozolomide and 3D conformal or intensity modulated radiation therapy (IMRT)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2017to 7 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed GBM using WHO criteria.
- Age ≥ 18 years
- Maximal debulking surgery (at the discretion of the investigator). Biopsy alone is not exclusionary.
- KPS ≥ 70
- Life expectancy of at least 3 months.
- Sexually active participants must agree to the strict use of barrier contraception.
Show all 17Show fewer
- Patients must be able to understand the investigational nature of the study and provide informed consent.
- Adequate hematologic function:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ) ≥ 100 x 109/L
- Hemoglobin ≥ 10 g /dL
- Adequate liver function
- Total bilirubin ≤ 1.5 x ULN
- AST and ALT ≤ 2.5 x ULN
- Adequate renal function
- Creatinine ≤ 1.25 x ULN
- 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).
Who cannot join
- Active participation in another clinical treatment trial. Concomitant protocols for data or tissue collection without intervention are permitted.
- Any prior treatment for GBM aside from surgery, including carmustine wafers.
- Women who are pregnant or nursing.
- 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:
- 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.
- Known HIV or other immunosuppressive disease, chronic hepatitis B or hepatitis C
Show all 14Show fewer
- Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.
- Implanted pacemaker, programmable shunt, cardiac defibrillator, deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias.
- Infratentorial glioblastoma.
- Past hypersensitivity reaction to temozolomide or DTIC.
- Psychiatric illness that compromises the informed consent process, at the discretion of the investigator.
- Inability or unwillingness to return for required visits.
- Previous cytotoxic therapy within the last 5 years.
- Inability to begin temozolomide concomitant to radiation therapy, for reasons 4 or 7 above.
Trial locations and contacts
1 site in 1 country.
United States1 site
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: Pilot Study of Concomitant NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma
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.
Read the detailed description
A prospective, single arm, non-randomized, open label pilot trial will enroll ten patients with histologically-confirmed newly diagnosed GBM who meet all eligibility criteria. Patients will be recruited to the study by the principal investigator (PI) or one of the co-investigators (CI) at one institution, Hackensack University Medical Center. Accrual is expected to continue for 18 months.
The protocol has a planned enrollment of 10 patients. Should patients discontinue treatment on protocol for reasons unrelated to toxicity (e.g. lost to follow-up, withdrawal of consent), additional patient (s) may be enrolled to complete enrollment.
Following maximal debulking surgery, patients will undergo a gadolinium enhanced brain MRI within 72 hours and a screening visit 2 to 4 weeks following surgery. Extent of resection will be recorded as biopsy, partial resection or gross-total resection based upon residual enhancing tumor on post-operative MRI.The day prior to XRT start, patients will have a clinic visit for training and application of the NovoTTF-200A device. During this visit, the patient will be educated regarding general use and maintenance of the device, with a particular focus upon strategies to prevent, identify and manage dermatologic adverse events (dAE). Temozolomide will be dosed nightly during XRT as per standard of care, and NovoTTF-200A will be worn continuously, removed during XRT and replaced as soon as possible thereafter.
During XRT and for 12 weeks to follow, the patient will have study visits at regular intervals (TAB A) for a physical examination and to assess toxicity and device compliance. Visits outlined in TAB A are in addition to weekly visits during radiotherapy with the treating radiation oncologist. MRI will be obtained at 4 weeks (+/-7 days) and 12 weeks (+/-7 days) following completion of XRT, and maintenance temozolomide will recommence in 5/28 day cycles as per standard of care. Objective response will be assessed as defined by the Response Assessment in Neuro-Oncology (RANO) criteria (TAB C) by the treating physician and confirmed by a second investigator.
In the case of suspected pseudoprogression, continued treatment and subsequent evaluations will help clarify whether it is true progression. Patients may continue treatment at the discretion of the investigator. If subsequent evaluations suggest that the tumor has in fact progressed, the date of progression will reflex to the date when the issue was first raised. However, if subsequent evaluations demonstrate improvement without change in therapy, the initial tumor increase may be considered pseudoprogression and response may be recorded as not evaluable for that time point. In the case of clinical progression, an unscheduled MRI will be obtained within 1 week of the investigator becoming aware of the clinical progression. No additional MRIs will be required after progression.
Temozolomide and NovoTTF-200A will continue until the final study visit, or until disease progression or unacceptable toxicity. Thereafter, temozolomide, MRI and response assessments will continue as per standard of care. Following the final study visit, the patient will be followed at a minimum of every two months for survival, either by phone or in person. If the patient is free of unacceptable toxicity attributable to NovoTTF-200A, they will be offered the opportunity to continue the device at no financial cost, but without obligation to do so.
Unacceptable toxicity includes the occurrence of device related serious adverse events or clinical and functional deterioration considered by the investigator to be prohibitive of continuing treatment. Treatment with the NovoTTF-200A device does not need to be terminated in the case of temozolomide toxicity.
The primary endpoint will be safety and tolerability of combined modality treatment with radiotherapy, temozolomide and NovoTTF-200A, based upon the incidence and severity of adverse events. Secondary endpoints will be overall survival, progression free survival and quality of life.
- Conditions
- Glioblastoma, Adult
- Being tested
- NovoTTF-200A, Temozolomide, 3D conformal or intensity modulated radiation therapy (IMRT)
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoTTF-200ADevice
Also called Optune
- 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.
TemozolomideDrug
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.
3D conformal or intensity modulated radiation therapy (IMRT)Radiation
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.
| Study group | Role | What they receive |
|---|---|---|
| NovoTTF-200A + Temozolomide Chemoradiation | Experimental | NovoTTF-200A, concomitant with radiotherapy and temozolomide, as front-line therapy for glioblastoma Receives: Device: NovoTTF-200A; Drug: Temozolomide; Radiation: 3D conformal or intensity modulated radiation therapy (IMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety and tolerability of combined modality treatment with radiotherapy, temozolomide and NovoTTF-200A based upon the incidence and severity of adverse events.
Measured: 24 months
Secondary outcomes (4)
Overall survival time
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).
Measured: 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
Progression free survival at 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).
Measured: 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
Quality of life assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30)
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.
Measured: 24 months
Quality of life assessed using a European Organization for Research and Treatment of Cancer (EORTC) Brain Cancer questionnaire (BN20)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start26 Jul 2017
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single arm, non-randomized, open label pilot
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd.
- Responsible party
- Sponsor
- Investigators
- Samuel Goldlust, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232424
- Sponsor's protocol ID
- Pro2017-0087
- Status last verified
- Nov 2024
- First submitted
- 17 Jul 2017
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.
PubMed 19269895Polk 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.
Palti Y. Stimulation of internal organs by means of externally applied electrodes. J Appl Physiol. 1966 Sep;21(5):1619-23. doi: 10.1152/jappl.1966.21.5.1619. No abstract available.
PubMed 5923236Bassett CA. The development and application of pulsed electromagnetic fields (PEMFs) for ununited fractures and arthrodeses. Clin Plast Surg. 1985 Apr;12(2):259-77.
PubMed 3886262Elson 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.
Takashima S, Schwan HP. Alignment of microscopic particles in electric fields and its biological implications. Biophys J. 1985 Apr;47(4):513-8. doi: 10.1016/S0006-3495(85)83945-X.
PubMed 3986280Zimmermann U, Vienken J, Pilwat G. Rotation of cells in an alternating electric field: the occurrence of a resonance frequency. Z Naturforsch C Biosci. 1981 Jan-Feb;36(1-2):173-7. doi: 10.1515/znc-1981-1-229.
PubMed 7010816Holzapfel C, Vienken J, Zimmermann U. Rotation of cells in an alternating electric field: theory and experimental proof. J Membr Biol. 1982;67(1):13-26. doi: 10.1007/BF01868644.
PubMed 7097755Pawlowski P, Szutowicz I, Marszalek P, Fikus M. Bioelectrorheological model of the cell. 5. Electrodestruction of cellular membrane in alternating electric field. Biophys J. 1993 Jul;65(1):541-9. doi: 10.1016/S0006-3495(93)81056-7.
PubMed 8369458Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.
PubMed 15126372Zhao M, Forrester JV, McCaig CD. A small, physiological electric field orients cell division. Proc Natl Acad Sci U S A. 1999 Apr 27;96(9):4942-6. doi: 10.1073/pnas.96.9.4942.
PubMed 10220398Jordan MA, Thrower D, Wilson L. Effects of vinblastine, podophyllotoxin and nocodazole on mitotic spindles. Implications for the role of microtubule dynamics in mitosis. J Cell Sci. 1992 Jul;102 ( Pt 3):401-16. doi: 10.1242/jcs.102.3.401.
PubMed 1506423Rowinsky EK, Donehower RC. Paclitaxel (taxol). N Engl J Med. 1995 Apr 13;332(15):1004-14. doi: 10.1056/NEJM199504133321507. No abstract available.
PubMed 7885406Kline-Smith SL, Walczak CE. The microtubule-destabilizing kinesin XKCM1 regulates microtubule dynamic instability in cells. Mol Biol Cell. 2002 Aug;13(8):2718-31. doi: 10.1091/mbc.e01-12-0143.
PubMed 12181341
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Concomitant NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT03232424
- Acronym / sponsor ID
- Pro2017-0087
- Conditions
- Glioblastoma, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- NovoCure Ltd.
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective, single arm, non-randomized, open label pilot trial will enroll ten patients with histologically-confirmed newly diagnosed GBM who meet all eligibility criteria. Patients will be recruited to the study by the principal investigator (PI) or one of the co-investigators (CI) at one institution, Hackensack University Medical Center. Accrual is expected to continue for 18 months.
The protocol has a planned enrollment of 10 patients. Should patients discontinue treatment on protocol for reasons unrelated to toxicity (e.g. lost to follow-up, withdrawal of consent), additional patient (s) may be enrolled to complete enrollment.
Following maximal debulking surgery, patients will undergo a gadolinium enhanced brain MRI within 72 hours and a screening visit 2 to 4 weeks following surgery. Extent of resection will be recorded as biopsy, partial resection or gross-total resection based upon residual enhancing tumor on post-operative MRI.The day prior to XRT start, patients will have a clinic visit for training and application of the NovoTTF-200A device. During this visit, the patient will be educated regarding general use and maintenance of the device, with a particular focus upon strategies to prevent, identify and manage dermatologic adverse events (dAE). Temozolomide will be dosed nightly during XRT as per standard of care, and NovoTTF-200A will be worn continuously, removed during XRT and replaced as soon as possible thereafter.
During XRT and for 12 weeks to follow, the patient will have study visits at regular intervals (TAB A) for a physical examination and to assess toxicity and device compliance. Visits outlined in TAB A are in addition to weekly visits during radiotherapy with the treating radiation oncologist. MRI will be obtained at 4 weeks (+/-7 days) and 12 weeks (+/-7 days) following completion of XRT, and maintenance temozolomide will recommence in 5/28 day cycles as per standard of care. Objective response will be assessed as defined by the Response Assessment in Neuro-Oncology (RANO) criteria (TAB C) by the treating physician and confirmed by a second investigator.
In the case of suspected pseudoprogression, continued treatment and subsequent evaluations will help clarify whether it is true progression. Patients may continue treatment at the discretion of the investigator. If subsequent evaluations suggest that the tumor has in fact progressed, the date of progression will reflex to the date when the issue was first raised. However, if subsequent evaluations demonstrate improvement without change in therapy, the initial tumor increase may be considered pseudoprogression and response may be recorded as not evaluable for that time point. In the case of clinical progression, an unscheduled MRI will be obtained within 1 week of the investigator becoming aware of the clinical progression. No additional MRIs will be required after progression.
Temozolomide and NovoTTF-200A will continue until the final study visit, or until disease progression or unacceptable toxicity. Thereafter, temozolomide, MRI and response assessments will continue as per standard of care. Following the final study visit, the patient will be followed at a minimum of every two months for survival, either by phone or in person. If the patient is free of unacceptable toxicity attributable to NovoTTF-200A, they will be offered the opportunity to continue the device at no financial cost, but without obligation to do so.
Unacceptable toxicity includes the occurrence of device related serious adverse events or clinical and functional deterioration considered by the investigator to be prohibitive of continuing treatment. Treatment with the NovoTTF-200A device does not need to be terminated in the case of temozolomide toxicity.
The primary endpoint will be safety and tolerability of combined modality treatment with radiotherapy, temozolomide and NovoTTF-200A, based upon the incidence and severity of adverse events. Secondary endpoints will be overall survival, progression free survival and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single arm, non-randomized, open label pilot
| Arm | Type | Receives |
|---|---|---|
| NovoTTF-200A + Temozolomide Chemoradiation | Experimental | Device: NovoTTF-200A, Drug: Temozolomide, Radiation: 3D conformal or intensity modulated radiation therapy (IMRT)NovoTTF-200A, concomitant with radiotherapy and temozolomide, as front-line therapy for glioblastoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed GBM using WHO criteria.
- Age ≥ 18 years
- Maximal debulking surgery (at the discretion of the investigator). Biopsy alone is not exclusionary.
- KPS ≥ 70
- Life expectancy of at least 3 months.
Key exclusion criteria (14 listed)
- Active participation in another clinical treatment trial. Concomitant protocols for data or tissue collection without intervention are permitted.
- Any prior treatment for GBM aside from surgery, including carmustine wafers.
- Women who are pregnant or nursing.
- 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:
- Implanted pacemaker, programmable shunt, cardiac defibrillator, deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovoTTF-200AAlso: Optune* 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. | Device | NovoTTF-200A + Temozolomide Chemoradiation |
| TemozolomideConcomitant 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. | Drug | NovoTTF-200A + Temozolomide Chemoradiation |
| 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. | Radiation | NovoTTF-200A + Temozolomide Chemoradiation |
Primary outcome
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.
4 secondary outcomes
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
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
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
Quality of life assessed using a European Organization for Research and Treatment of Cancer (EORTC) Brain Cancer questionnaire (BN20)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Background: PubMed 19269895Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.
- BackgroundPolk 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.
- Background: PubMed 5923236Palti Y. Stimulation of internal organs by means of externally applied electrodes. J Appl Physiol. 1966 Sep;21(5):1619-23. doi: 10.1152/jappl.1966.21.5.1619. No abstract available.
- Background: PubMed 3886262Bassett CA. The development and application of pulsed electromagnetic fields (PEMFs) for ununited fractures and arthrodeses. Clin Plast Surg. 1985 Apr;12(2):259-77.
- BackgroundElson 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.
- BackgroundChou CK. Radiofrequency hyperthermia in cancer therapy. In: Bronzino JD ed. The biomedical engineering handbook. Connecticut: CRC Press, 1995:1424-1430.
- Background: PubMed 3986280Takashima S, Schwan HP. Alignment of microscopic particles in electric fields and its biological implications. Biophys J. 1985 Apr;47(4):513-8. doi: 10.1016/S0006-3495(85)83945-X.
- Background: PubMed 7010816Zimmermann U, Vienken J, Pilwat G. Rotation of cells in an alternating electric field: the occurrence of a resonance frequency. Z Naturforsch C Biosci. 1981 Jan-Feb;36(1-2):173-7. doi: 10.1515/znc-1981-1-229.
- Background: PubMed 7097755Holzapfel C, Vienken J, Zimmermann U. Rotation of cells in an alternating electric field: theory and experimental proof. J Membr Biol. 1982;67(1):13-26. doi: 10.1007/BF01868644.
- Background: PubMed 8369458Pawlowski P, Szutowicz I, Marszalek P, Fikus M. Bioelectrorheological model of the cell. 5. Electrodestruction of cellular membrane in alternating electric field. Biophys J. 1993 Jul;65(1):541-9. doi: 10.1016/S0006-3495(93)81056-7.
- Background: PubMed 15126372Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.
- Background: PubMed 10220398Zhao M, Forrester JV, McCaig CD. A small, physiological electric field orients cell division. Proc Natl Acad Sci U S A. 1999 Apr 27;96(9):4942-6. doi: 10.1073/pnas.96.9.4942.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Goldlust, MD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NovoTTF-200A, Temozolomide and 3D conformal or intensity modulated radiation therapy (IMRT) in people with Glioblastoma, Adult, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03232424, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.