TTFields Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM

NCT03780569 | Unknown

• 1 other identifier: ICH-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a prospective, single arm open label study, designed to test the to evaluate the tolerability and safety outcome of newly diagnosed GBM patients treated with NovoTTF-200A concomitant to Radiotherapy/Temozolomide followed by Temozolomide. The device is a portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Conditions

Glioblastoma Multiforme

Keywords

GBM; TTFields; Tumor Treating Fields; Glioblastoma; Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Safety of concomitant Radiotherapy/Temozolomide with NovoTTF-200A: The incidence of Radiotherapy treatment delays during concomitant Radiotherapy/Temozolomide/NovoTTF-200A will be documented including severity and relationship to NovoTTF-200A.

  The incidence of Radiotherapy treatment delays during concomitant Radiotherapy/Temozolomide/NovoTTF-200A will be documented including severity and relationship to NovoTTF-200A.

  2 years

Secondary Outcomes (3)

• Progression free survival

  2 years

• Overall survival

  2 years

• Adverse events, severity and frequency

  2 years

Study Arms (1)

NovoTTF-200A/Radiotherapy/Temozolomide

EXPERIMENTAL

Patients will receive multiple 1 month courses of continuous NovoTTF-200A treatment together with standard Radiotherapy/Temozolomide followed by maintenance Temozolomide.

Device: NovoTTF-200A; Radiation: Radiotherapy; Drug: Temozolomide

Interventions

NovoTTF-200A DEVICE

Patients receive continuous TTFields treatment using the NovoTTF-200A device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the scalp. The treatment enables the patient to maintain regular daily routine.

NovoTTF-200A/Radiotherapy/Temozolomide

Radiotherapy RADIATION

60Gy given in 30 2Gy fractions concomitant to temozolomide

NovoTTF-200A/Radiotherapy/Temozolomide

Temozolomide DRUG

Temozolomide(TMZ) will be administered at 75 mg/m\^2 concomitant to radiotherapy(RT) and NovoTTF-200A. Maintenance treatment is to begin about 4 weeks after the end of TMZ/RT/NovoTTF-200A. TMZ is administered at the conventional dosing regimen for 5 days, every 28 days (i.e. 5 days of therapy, 23 days of rest). Cycle 1 is to be given at a dose of 150 mg/m\^2 p.o. daily x 5 days, dose to be escalated to 200 mg/m\^2 in the absence of toxicity.

NovoTTF-200A/Radiotherapy/Temozolomide

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed diagnosis of GBM according to WHO classification criteria.
• Supratentorial tumor location
• Age ≥ 18 years
• Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection and biopsy-only patients are all acceptable)
• Planned treatment with adjuvant/maintenance TMZ (150-200 mg/m\^2 daily x 5 d, q28 days)
• Karnofsky performance status ≥ 70
• Life expectancy ≥ 3 months
• Participants of childbearing age must use effective contraception.
• All patients must sign written informed consent.
• NovoTTF-200A treatment start date at least 2 weeks out from brain surgery.
• NovoTTF-200A treatment start prior to or at the beginning of RT/TMZ
• Stable or decreasing dose of corticosteroids for the last 7 days prior to enrollment, if applicable.

You may not qualify if:

• Participation in another clinical treatment trial
• Pregnancy or breast feeding
• Significant co-morbidities at baseline which would preclude TMZ treatment
• Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
• Infra-tentorial tumor location
• Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
• History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC.
• Known allergies to medical adhesives or gel

Sponsors & Collaborators

• NovoCure Ltd.: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Related Publications (2)

• 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

• 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.

  PMID: 29260225 BACKGROUND

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiotherapy; Temozolomide

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

Intervention Hierarchy (Ancestors)

Therapeutics; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 19, 2018
• Study Start: April 27, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: December 20, 2018

Record last verified: 2018-12

Locations

IL (1)