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AzTrials

GlioblastomaEarly Phase 1NCT03477110

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

A Early Phase 1 study testing Temozolomide, Radiation Therapy and NovoTTF-200A Device in people with Glioblastoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Temozolomide, Radiation Therapy and NovoTTF-200A Device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
4 May 2018to 26 Jan 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: SPARE-Scalp Preservation and Radiation Plus Alternating Electric Tumor Treatment Field (NovoTTF, Optune) for Patients With Glioblastoma: A Pilot Study

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:

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

SECONDARY OBJECTIVES:

  1. 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.

  1. To evaluate the quality of life of patients treated with radiotherapy with concurrent and adjuvant temozolomide plus Optune.
Conditions
Glioblastoma
Being tested
Temozolomide, Radiation Therapy, NovoTTF-200A Device, Tumor Treating Fields Therapy
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TemozolomideDrug

    Also called 362856, Temcad, Temodal, Methazolastone

    Given PO

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Irradiate, RT

    Undergo radiation therapy

  • NovoTTF-200A DeviceDevice

    Also called Optune

    Undergo tumor treatment fields therapy using NovoTTF-200A device

  • Tumor Treating Fields TherapyProcedure or surgery

    Also called Alternating Electric Field Therapy

    Undergo tumor treatment fields therapy using NovoTTF-200A device

Study groups in NCT03477110
Study groupRoleWhat they receive
Treatment (temozolomide, radiation, NovoTTF-200A device)ExperimentalParticipants 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.
Receives: Drug: Temozolomide; Radiation: Radiation Therapy; Device: NovoTTF-200A Device; Procedure: Tumor Treating Fields Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 30 days after finishing chemoradiation treatment

Secondary outcomes (3)

  1. Progression-free survival

    Will be evaluated using the Kaplan-Meier method.

    Measured: From enrollment up to 1 year

  2. Overall survival

    Will be evaluated using the Kaplan-Meier method.

    Measured: From enrollment up to 1 year

  3. Event-free survival

    Will be evaluated using the Kaplan-Meier method.

    Measured: From enrollment up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2018
  2. Study start4 May 2018
  3. Primary completion21 Apr 2021
  4. Study completion26 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03477110
Sponsor's protocol ID
17P.346
Other IDs
JT 10706
Status last verified
May 2025
First submitted
19 Mar 2018
Last updated
15 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Temozolomide, Radiation Therapy and NovoTTF-200A Device in people with Glioblastoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NovoTTF-200A device discontinuation rate due to skin toxicity (time frame: Up to 30 days after finishing chemoradiation treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03477110, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

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