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

Purpose

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.

Condition	Intervention	Phase
Recurrent Glioblastoma Multiforme	Device: NovoTTF-100A	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective, Non-randomized, Concurrent Control, Open Label, Post-approval Study of NovoTTF-100A in Recurrent GBM Patient

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by NovoCure Ltd.:

Primary Outcome Measures:

Overall Survival [ Time Frame: 5 years from initiation of accrual ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in neuro-cognitive function from baseline based on MMSE [ Time Frame: 5 years from initiation of accrual ] [ Designated as safety issue: No ]
Genetic profiling of tumors and correlation with response to NovoTTF-100A treatment [ Time Frame: 5 years from initiation of accrual ] [ Designated as safety issue: No ]
Adverse events severity and frequency [ Time Frame: 5 years from initiation of accrual ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	486
Study Start Date:	December 2012
Estimated Study Completion Date:	January 2018
Estimated Primary Completion Date:	January 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Best Standard of Care Patients recruited to the BSC group will be treated according to the BSC practiced at each center.	Device: NovoTTF-100A Multiple four-week courses of continuous NovoTTF-100A treatment.
Experimental: NovoTTF-100A (monotherapy) 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 Multiple four-week courses of continuous NovoTTF-100A treatment.

Show Detailed Description

Eligibility

Ages Eligible for Study:	22 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

22 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

Exclusion Criteria:

Implanted electronic medical device in the brain:
1. Deep brain stimulator
2. Vagus nerve stimulator
3. 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756729

Contacts

Contact: Ghazala Kabani

patientinfo@novocure.com

Locations

United States, California
University of California San Diego Moores Cancer Center	Recruiting
La Jolla, California, United States, 92093
Contact: Angel Nguyen 858-822-0201 anguyen85@ucsd.edu
Principal Investigator: Santosh Kesari, M.D., PhD.
United States, Illinois
University of Illinois at Chicago	Recruiting
Chicago, Illinois, United States, 60612
Contact: Herbert Engelhard, MD, PhD 312-282-5821 hengel@uic.edu
Principal Investigator: Herbert Engelhard, MD, PhD

Sponsors and Collaborators

NovoCure Ltd.

Investigators

Principal Investigator:

Herbert Engelhard, MD, PhD

University of Illinois

More Information

Publications:

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.

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. Epub 2007 Jun 5.

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.

Responsible Party:	NovoCure Ltd.
ClinicalTrials.gov Identifier:	NCT01756729 History of Changes
Other Study ID Numbers:	EF-19
Study First Received:	December 20, 2012
Last Updated:	April 2, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by NovoCure Ltd.:

Brain tumor
Treatment
Minimal toxicity
GBM

Glioblastoma
Recurrent
TTFields

Additional relevant MeSH terms:

Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 21, 2013