Glioblastoma Multiforme Clinical Trial
Official title:
EF-33: An Open-Label Pilot Study of OPTUNE® (TTFields, 200 Khz) With High Density Transducer Arrays for the Treatment of Recurrent Glioblastoma
NCT number | NCT04492163 |
Other study ID # | EF-33 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 14, 2020 |
Est. completion date | January 2022 |
This is a prospective, open-label, single arm, historical control pilot study aimed to test the effectiveness and safety of TTFields delivered through high intensity arrays in recurrent glioblastoma. The Optune® System is an investigational , portable, battery operated medical device in this study delivering 200 kHz TTFields to the brain using high intensity transducer arrays for the treatment of patients at the age of 18 years or older with first or second recurrence of Glioblastoma Multiforme (GBM)
Status | Recruiting |
Enrollment | 25 |
Est. completion date | January 2022 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Histologically confirmed diagnosis of GBM according to WHO classification criteria. 2. Age = 18 years 3. Not a candidate for further radiotherapy or additional resection of residual tumor. 4. Patients with first or second radiological disease progression per RANO criteria documented by MRI within 4 weeks prior to starting therapy with the following restriction: disease progression must be either growth of the enhancing lesion or a new lesion. 5. Karnofsky performance status = 70 6. Life expectancy = least 3 months 7. Participants of childbearing age must use highly effective contraception. An effective method of birth control is defined as one that results in a failure rate of less than 1% per year when used consistently and correctly. The Investigator must approve the selected method, and may consult with a gynecologist as needed. 8. All patients must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted. 9. Treatment start date at least 4 weeks out from brain surgery chemotherapy or irradiation therapy. Exclusion Criteria: 1. Infratentorial or leptomeningeal disease 2. Treatment with Optune® (for newly diagnosed or recurrent disease) prior to enrollment. 3. Participation in another clinical treatment study during screening and treatment phase of the study. 4. Pregnancy or breast-feeding. 5. Significant co-morbidities at baseline, as determined by the investigator: 1. Thrombocytopenia (platelet count < 100 x 103/µL) 2. Neutropenia (absolute neutrophil count < 1 x 103/µL) 3. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting) 4. Significant liver function impairment - AST or ALT > 3 times the upper limit of normal 5. Total bilirubin > 1.5 x upper limit of normal 6. Significant renal impairment (serum creatinine > 1.7 mg/dL, or > 150 µmol/l) 7. History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent 6. Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias. 7. Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness) 8. Admitted to an institution by administrative or court order. 9. Known allergies to medical adhesives or hydrogel - |
Country | Name | City | State |
---|---|---|---|
Czechia | Nemocnice Na Homolce | Prague |
Lead Sponsor | Collaborator |
---|---|
NovoCure Ltd. |
Czechia,
Ballo MT, Urman N, Lavy-Shahaf G, Grewal J, Bomzon Z, Toms S. Correlation of Tumor Treating Fields Dosimetry to Survival Outcomes in Newly Diagnosed Glioblastoma: A Large-Scale Numerical Simulation-Based Analysis of Data from the Phase 3 EF-14 Randomized Trial. Int J Radiat Oncol Biol Phys. 2019 Aug 1;104(5):1106-1113. doi: 10.1016/j.ijrobp.2019.04.008. Epub 2019 Apr 23. — View Citation
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Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046. — View Citation
Kirson ED, Dbalý V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. Epub 2007 Jun 5. — View Citation
Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23. — View Citation
Kirson 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. — View Citation
Mun EJ, Babiker HM, Weinberg U, Kirson ED, Von Hoff DD. Tumor-Treating Fields: A Fourth Modality in Cancer Treatment. Clin Cancer Res. 2018 Jan 15;24(2):266-275. doi: 10.1158/1078-0432.CCR-17-1117. Epub 2017 Aug 1. Review. — View Citation
Pless M, Weinberg U. Tumor treating fields: concept, evidence and future. Expert Opin Investig Drugs. 2011 Aug;20(8):1099-106. doi: 10.1517/13543784.2011.583236. Epub 2011 May 9. Review. — View Citation
Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718. Erratum in: JAMA. 2018 May 1;319(17):1824. — View Citation
Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbalý V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival (PFS) | PFS will be measured from the date of enrollment to date of progression (in months) based on RANO citeria. | 18 Months | |
Secondary | Overall Survival (OS) | Survival will be measured from date of enrollment until date of death. | 18 Months | |
Secondary | Progression Free Survival at 6 months (PFS6) | The analysis will be estimated proportions of patients who are progression-free at 6 months based on the RANO criteria following the time of enrollment. | 18 Months | |
Secondary | 1-year and 2-year survival rates | The analyses will be performed based on estimated proportions of patients who are alive at one and two years following enrollment. | 24 Months | |
Secondary | Overall radiological response | The percentage of patients who had either complete response or partial response per RANO criteria following enrollment | 18 Months | |
Secondary | Severity and frequency of adverse events | The analyses will be performed based on the incidence, severity, frequency of adverse events, and their association with study treatments | 18 Months | |
Secondary | Pathological changes in resected GBM tumors following study treatment | Pathological changes in the tumors of patients who consented to have pathological analysis of their tumors and also underwent another surgical resection while on the study | 18 Months | |
Secondary | Dependence of Progression Free Survival on TTFields dose delivered to the tumor bed | 18 months | ||
Secondary | Dependence of Overall Survival on TTFields dose delivered to the tumor bed | 18 months |
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