CompletedNCT03477110Updated May 15, 2025

Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma

An Early Phase 1 interventional study of Temozolomide and Radiation Therapy in Glioblastoma, sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.

Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University · Early Phase 1, Interventional, and Treatment

Phase: Early Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

This pilot early phase I trial studies the side effects of temozolomide, radiation therapy, and tumor treating fields therapy using Novo tumor treatment fields (TTF)-200A device in participants with glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. NovoTTF-200A device is a portable device that produces alternating electrical fields that may disrupt growth of cancer cells. Giving temozolomide, radiation therapy, and tumor treating fields therapy using NovoTTF-200A device may work better in treating participants with glioblastoma.

Read the detailed description

PRIMARY OBJECTIVES:

I. To evaluate the safety and toxicity of combination chemoradiotherapy with NovoTTF-200A device (Optune) treatment in newly diagnosed glioblastoma.

SECONDARY OBJECTIVES:

I. To determine the median progression-free survival of patients with newly diagnosed glioblastoma treated with radiotherapy with concurrent and adjuvant temozolomide plus Optune.

II. To evaluate the median overall survival, 1-year overall survival, and event-free survival.

III. Collect tumor O(6)-Methylguanine-DNA-methyltransferase (MGMT) methylation status and isocitrate dehydrogenase (IDH) mutation status.

IV. To evaluate the level of circulating tumor deoxyribonucleic acid (DNA) in glioblastoma patient serum during treatment.

V. To evaluate the quality of life of patients treated with radiotherapy with concurrent and adjuvant temozolomide plus Optune.

Conditions studied

Glioblastoma

Browse trials for

Glioblastoma 1,917

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients with pathology confirmed newly diagnosed World Health Organization (WHO) grade IV glioma
Karnofsky performance status (KPS) ≥ 60
Patients must have recovered from the effects of surgery per treating physician's judgment; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment; for core or needle biopsy, a minimum of 14 days must have elapsed prior to the day of protocol treatment
Absolute neutrophil count (ANC) ≥ 1,000 cells/mm\^3
Platelets ≥ 100,000 cells/mm\^3
Hemoglobin ≥ 9.0 g/dl
Creatinine clearance > 30 mL/min
Bilirubin \< 2.0 mg/dL
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 3 x upper limit of normal range
Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to registration
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose of temozolomide
Is able to have magnetic resonance imaging (MRI) with contrast of the brain
All subjects must be able to comprehend and sign a written informed consent document. If the subject can comprehend the informed consent but is unable to sign, a LAR may sign the written informed consent document.

Exclusion criteria

Exclusion Criteria:

Infratentorial disease (defined as glioblastoma [GBM] derived from cerebellum or brainstem)
Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
A skull defect (such as, missing bone with no replacement)
Women of childbearing potential who are pregnant or breastfeeding
Evidence of increased intracranial pressure (midline shift > 5 mm, clinically significant papilledema)
Serious medical or psychiatric illness likely to interfere with participation in this clinical study, in the opinion of the investigator
Prior radiation treatment to the brain
Prior treatment with temozolomide
Known hypersensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
Known active collagen vascular disease

Study design

Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

Experimental
Treatment (temozolomide, radiation, NovoTTF-200A device)
Participants receive temozolomide PO QD starting day 1 to the end of radiation therapy and undergo 30 fractions of radiation therapy over 15-20 minutes each, 5 days a week (Monday-Friday) for 6 weeks. Beginning day 1 of radiation therapy, participants undergo tumor treatment fields therapy using NovoTTF-200A device over 18 hours or more daily in the absence of disease progression or unacceptable toxicity. Beginning 28 days after the last dose of radiation therapy, participants receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Drug: Temozolomide · Radiation: Radiation Therapy · Device: NovoTTF-200A Device · Procedure: Tumor Treating Fields Therapy

Interventions

DrugTemozolomide
Given PO
Also known as: 362856, Temcad, Temodal, Methazolastone, Temodar
RadiationRadiation Therapy
Undergo radiation therapy
Also known as: Cancer Radiotherapy, Irradiate, RT
DeviceNovoTTF-200A Device
Undergo tumor treatment fields therapy using NovoTTF-200A device
Also known as: Optune
ProcedureTumor Treating Fields Therapy
Undergo tumor treatment fields therapy using NovoTTF-200A device
Also known as: Alternating Electric Field Therapy

What researchers measure

Primary outcomes

NovoTTF-200A device discontinuation rate due to skin toxicity
Discontinuation events are defined as the discontinuation of NovoTTF-200A device for \> 7 consecutive days due to skin toxicity of grade 3 or higher. For discontinuation rates, the method of Atkinson and Brown will be used to allow for the two-stage design. Descriptive analysis will be performed on the acute toxicity data.
Time frame: Up to 30 days after finishing chemoradiation treatment

Secondary outcomes

Progression-free survival
Will be evaluated using the Kaplan-Meier method.
Time frame: From enrollment up to 1 year
Overall survival
Will be evaluated using the Kaplan-Meier method.
Time frame: From enrollment up to 1 year
Event-free survival
Will be evaluated using the Kaplan-Meier method.
Time frame: From enrollment up to 1 year

Study locations

1 site

Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania 19107, United States

References and documents

Publications

Ali AS, Lombardo J, Niazi MZ, Miller RC, Alnahhas I, Martinez NL, Andrews DW, Judy KD, Shi W. Concurrent chemoradiation and Tumor Treating Fields (TTFields, 200 kHz) for patients with newly diagnosed glioblastoma: patterns of progression in a single institution pilot study. J Neurooncol. 2022 Nov;160(2):345-350. doi: 10.1007/s11060-022-04146-w. Epub 2022 Nov 10. PubMed 36355259 ↗
Miller R, Song A, Ali A, Niazi M, Bar-Ad V, Martinez N, Glass J, Alnahhas I, Andrews D, Judy K, Evans J, Farrell C, Werner-Wasik M, Chervoneva I, Ly M, Palmer J, Liu H, Shi W. Scalp-Sparing Radiation With Concurrent Temozolomide and Tumor Treating Fields (SPARE) for Patients With Newly Diagnosed Glioblastoma. Front Oncol. 2022 Apr 29;12:896246. doi: 10.3389/fonc.2022.896246. eCollection 2022. PubMed 35574391 ↗
Song A, Bar-Ad V, Martinez N, Glass J, Andrews DW, Judy K, Evans JJ, Farrell CJ, Werner-Wasik M, Chervoneva I, Ly M, Palmer JD, Liu H, Shi W. Initial experience with scalp sparing radiation with concurrent temozolomide and tumor treatment fields (SPARE) for patients with newly diagnosed glioblastoma. J Neurooncol. 2020 May;147(3):653-661. doi: 10.1007/s11060-020-03466-z. Epub 2020 Mar 23. PubMed 32206976 ↗

Individual participant data

Plan to share: Undecided

Registry details

Key details

Study ID: NCT03477110
Lead sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators: NovoCure Ltd.
Responsible party: Sponsor
First posted: Mar 26, 2018
Start date: May 4, 2018
Primary completion: Apr 21, 2021
Completion: Jan 26, 2024
Last update: May 15, 2025

Study contacts

Wenyin Shi, MD

principal investigator · Sidney Kimmel Cancer Center at Thomas Jefferson University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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