Niraparib/TTFields in GBM

STATUS

Recruiting
End date

Dec 28, 2025
participants needed

30
sponsor

University of Pennsylvania

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Updated on 19 February 2024

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renal function

niraparib

MRI

karnofsky performance status

renal function test

glioblastoma multiforme

recurrent glioblastoma

glioblastoma

tumor treating fields therapy

Summary

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Evaluating the efficacy and safety of niraparib and Tumor-Treating Fields (TTFields) in recurrent glioblastoma (GBM).

Description

Tumor-treating fields (TTFields) causes downregulation of BRCA1 signaling and reduced deoxyribonucleic acid (DNA) double-strand break repair capacity. Tumors that are deficient in the homologous recombination DNA damage repair pathway are highly sensitive to blockade of the repair of single strand DNA breaks via poly-ADP ribose polymerase (PARP) inhibition. This is a study of niraparib, a PARP inhibitor, in combination with tumor-treating fields for recurrent glioblastoma. We hypothesize that tumor-treating fields will induce a state of "BRCAness" in the glioma tumor cells, thus sensitizing them to PARP inhibition and resulting in tumor cell death.

Details

Condition	Glioblastoma Multiforme, Glioblastoma Multiforme, Glomerular Basement Membrane, Recurrent Glioblastoma
Age	22years - 100years
Treatment	Niraparib, Optune, Planned surgical resection
Clinical Study Identifier	NCT04221503
Sponsor	University of Pennsylvania
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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, completed and signed by a pathologist
	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
	Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain
	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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Niraparib/TTFields in GBM