Post-approval Study of NovoTTF-100A in Recurrent GBM Patients

NCT01756729 | Terminated Phase 4

• 1 other identifier: EF-19
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 12

Brief Summary

This is a non-randomized, concurrent control study, designed to confirm that the efficacy of the NovoTTF-100A System in patients with recurrent GBM treated in a real life settings following approval is comparable to that of BSC chemotherapy patients. The device is a portable, battery operated device that was approved for the treatment of adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM), following histologically- or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Conditions

Recurrent Glioblastoma Multiforme

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  5 years from initiation of accrual

Secondary Outcomes (3)

• Change in neuro-cognitive function from baseline based on MMSE

  5 years from initiation of accrual

• Genetic profiling of tumors and correlation with response to NovoTTF-100A treatment

  5 years from initiation of accrual

• Adverse events severity and frequency

  5 years from initiation of accrual

Study Arms (2)

Best Standard of Care

ACTIVE COMPARATOR

Patients recruited to the BSC group will be treated according to the BSC practiced at each center.

Device: NovoTTF-100A

NovoTTF-100A (monotherapy)

EXPERIMENTAL

Patients will be treated continuously with the NovoTTF-100A device. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.

Device: NovoTTF-100A

Interventions

NovoTTF-100A DEVICE

Multiple four-week courses of continuous NovoTTF-100A treatment.

Best Standard of Care; NovoTTF-100A (monotherapy)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Histological diagnosis of GBM (WHO grade IV)
• Tumor located in the supra-tentorial region of the brain
• Received maximal, safe, surgical resection
• Received maximal radiation therapy
• Received concomitant Temozolomide
• Received maintenance Temozolomide
• First recurrence (based on radiological or histological evidence of recurrence)
• Karnofsky performance score 70 or above
• MMSE score 25 or above
• Adequate amount and quality of tumor tissue from first surgical resection available for genetic profiling
• Women of childbearing age must be on effective contraception
• Signed informed consent
• Stable steroid dose in past 4 weeks

You may not qualify if:

• Implanted electronic medical device in the brain:
• Deep brain stimulator
• Vagus nerve stimulator
• Programmable shunt
• Skull defect without replacement
• Unable to comply with treatment with the NovoTTF-100A device
• Pregnant
• Prior antiangiogenic therapy (e.g., Bevacizumab/Avastin)
• Second or subsequent recurrence
• Any prior cytotoxic chemotherapy except Temozolomide
• Actively participating in another therapeutic clinical trial
• Radiological suspicion of pseudoprogression or radionecrosis
• Radiation therapy or surgery in the past 4 weeks
• Unable to comply with the study follow-up schedule
• Any serious co-morbidity which is expected to affect survival more adversely than GBM

Sponsors & Collaborators

• NovoCure Ltd.: lead

Study Sites (12)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0111, United States

Location

Barrow Neurology Clinics

Phoenix, Arizona, 85013, United States

Location

University of California San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, 40536-0093, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Washington University School of Medicine, Division of Oncology

St Louis, Missouri, 63110, United States

Location

The Long Island Brain Tumor Center

Lake Success, New York, 11042, United States

Location

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Baylor Research Institute

Dallas, Texas, 75246, United States

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

• 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 BACKGROUND

• Zhu JJ, Goldlust SA, Kleinberg LR, Honnorat J, Oberheim Bush NA, Ram Z. Tumor Treating Fields (TTFields) therapy vs physicians' choice standard-of-care treatment in patients with recurrent glioblastoma: a post-approval registry study (EF-19). Discov Oncol. 2022 Oct 14;13(1):105. doi: 10.1007/s12672-022-00555-5.

  PMID: 36239858 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

• Herbert Engelhard, MD, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 27, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 2, 2016

Record last verified: 2016-02

Locations

US (12)