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Electric fields and pill combo takes on deadly brain tumor

NCT ID NCT04221503

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests a combination of the drug niraparib and a device that delivers electric fields (Tumor-Treating Fields) in 30 people with recurrent glioblastoma, an aggressive brain cancer. The goal is to see if the combo can control the tumor, shrink it, or keep it stable. Participants must have had prior radiation and have measurable disease on MRI.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
niraparib (a PARP inhibitor) and Tumor-Treating Fields (electric fields delivered via a device)
What this could lead to
If it works, this could offer a new way to control recurrent glioblastoma, potentially slowing tumor growth and extending life.
What could go wrong
This is a small, early-phase trial with only 30 people, so results may not apply to everyone. The combination may cause side effects or fail to improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histopathologically or molecularly (per c-IMPACT NOW criteria) proven diagnosis of glioblastoma which is recurrent following radiation therapy (prior dose must have been between 40 and 75 Gy). * Tumor O-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) methylation status must be available from any prior GBM tumor specimen. * Patients must have measurable contrast-enhancing disease (defined by at least 1cm x 1cm) by magnetic resonance imaging (MRI) imaging within 28 days of starting study treatment. * Patients may have had treatment for an unlimited number of prior relapses. * Patients must have recovered from severe toxicity of prior therapy. * Patients must be able to swallow oral medications. * Karnofsky performance status \>= 60. * Life expectancy \>3 months. * Adequate hematologic parameters. * Adequate hepatic function within 7 days prior to start of study treatment. * Adequate renal function within 7 days prior to start of study treatment. * Reproductive Status * Women - negative serum or urine pregnancy test * Men and Women - must agree to an adequate method to avoid pregnancy * Participant must agree to not donate blood during the study or for 90 days after the last dose of niraparib. * Participant must, in the opinion of the Investigator, be able to comply with study procedures, including use of the Optune device. * Cohort B (surgical) patients only: patients must be undergoing surgery that is clinically indicated as determined by their care providers. * Cohort B (surgical) patients only: patients must have a tumor tissue form indicating availability of archived tissue from a previous surgery for glioblastoma. * Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent (or have legally authorized representative sign on patient's behalf if patient physically unable to sign consent due to neurologic deficit). Exclusion Criteria: * Age \< 22 years. * Prior treatment with tumor-treating fields therapy (Optune) within the past 6 months. * Prior treatment with a PARP inhibitor. * Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML). * Patients with infratentorial tumor. * Participant has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \> 4 weeks and was related to the most recent treatment. * Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. * Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain. Non-programmable shunts are allowed. Patients with a programmable shunt are excluded. * Skull defects. * Known hypersensitivity to conductive hydrogels or known hypersensitivity to niraparib components or excipients. * Patients with gastrointestinal disorders or abnormalities that would interfere with absorption of study treatment. * Prisoners or subjects who are involuntarily incarcerated. * Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. * Participant must not be simultaneously enrolled in any interventional clinical trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.