Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM)

NCT00379470 | Completed Phase 3 DMC

• 1 other identifier: EF-11
• Study Type: interventional
• Target: 236
• Locations: 7 countries
• Sites: 25

Brief Summary

The study is a randomized, controlled trial, designed to test the efficacy and safety of a new medical device, the NovoTTF-100A. The device is an experimental, portable, battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme (GBM) using alternating electric fields (termed TTFields).

Conditions

Recurrent Glioblastoma Multiforme

Keywords

Brain tumor; Treatment; Minimal toxicity; GBM; Glioblastoma; Recurrent; TTFields

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  2 years from initiation of accrual

Secondary Outcomes (6)

• Progression free survival at 6 months (PFS6)

  2 years from initiation of accrual

• Median Time to Disease Progression (TTP)

  2 years from initiation of accrual

• % 1-year survival

  2 years from initiation of accrual

• Radiological response (Macdonald criteria)

  2 years from initiation of accrual

• Quality of life assessment (EORTC QLQ-C30)

  2 years from initiation of accrual

Study Arms (2)

Best Standard of Care

ACTIVE COMPARATOR

Patients randomized to the BSC group will be treated with one chemotherapy according to the BSC practiced at each center.

Device: NovoTTF-100A

NovoTTF-100A

EXPERIMENTAL

Device: NovoTTF-100A

Interventions

NovoTTF-100A DEVICE

multiple four-week courses of continuous NovoTTF-100A treatment

Best Standard of Care; NovoTTF-100A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological evidence of GBM using WHO classification criteria.
• \> 18 years of age.
• Not a candidate for further radiotherapy or additional resection of residual tumor.
• Patients with disease progression (by Macdonald criteria i.e., \> 25% or new lesion) documented by CT or MRI within 4 weeks prior to enrollment
• Karnofsky scale ≥ 70
• Life expectancy at least 3 months
• Participants of childbearing age must use effective contraception.
• All patients must sign written informed consent.

You may not qualify if:

• Actively participating in another clinical treatment trial
• Within 4 weeks from surgery for recurrence
• Within 4 weeks from any prior chemotherapy.
• Within 4 weeks from radiation therapy
• Pregnant
• Significant co-morbidities (within 4 weeks prior to enrollment):
• Significant liver function impairment - AST or ALT \> 3 times the upper limit of normal
• Total bilirubin \> upper limit of normal
• Significant renal impairment (serum creatinine \> 1.7 mg/dL)
• Coagulopathy (as evidenced by PT or APTT \>1.5 times control in patients not undergoing anticoagulation)
• Thrombocytopenia (platelet count \< 100 x 103/μL)
• Neutropenia (absolute neutrophil count \< 1 x 103/μL)
• Anemia (Hb \< 10 g/L)
• Severe acute infection
• Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias.

Sponsors & Collaborators

• NovoCure Ltd.: lead

Study Sites (25)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Illinois in Chicago

Chicago, Illinois, 60612, United States

Location

Evanston Northwestern Healthcare

Evanston, Illinois, 60201, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Clinic Medical Center

Burlington, Massachusetts, 01850, United States

Location

NJ Neuroscience Institute - JFK Medical Center

Edison, New Jersey, 08818, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15232, United States

Location

University of Virginia

Charlottesville, Virginia, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

University Hospital Graz

Graz, Austria

Location

FN Brno - Masaryk University

Brno, Czechia

Location

Na Homolce Hospital

Prague, Czechia

Location

Hospital of Neurology Lyon - University Claude Bernard Lyon 1

Lyon, France

Location

Group Hospitals Pitie-Salpetriere

Paris, France

Location

University Hospital Augsburg

Augsburg, Germany

Location

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

University Hospital of Schleswig-Holstein

Kiel, 24105, Germany

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Related Publications (4)

• 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. doi: 10.1158/0008-5472.can-04-0083.

  PMID: 15126372 BACKGROUND

• Kirson ED, Dbaly 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. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.

  PMID: 17551011 BACKGROUND

• Salzberg M, Kirson E, Palti Y, Rochlitz C. A pilot study with very low-intensity, intermediate-frequency electric fields in patients with locally advanced and/or metastatic solid tumors. Onkologie. 2008 Jul;31(7):362-5. doi: 10.1159/000137713. Epub 2008 Jun 24.

  PMID: 18596382 BACKGROUND

• Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly 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.

  PMID: 22608262 DERIVED

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Phillip Gutin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Roger Stupp, MD

  University of Lausanne Hospital - Multidisciplinary Oncology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2006
• First Posted: September 21, 2006
• Study Start: September 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: January 1, 2011
• Last Updated: May 1, 2012

Record last verified: 2012-04

Locations

IL (1); CH (1); AU (1); DE (3); CZ (2); US (15); FR (2)