Niraparib/TTFields in GBM

  • STATUS
    Recruiting
  • End date
    Dec 18, 2025
  • participants needed
    30
  • sponsor
    University of Pennsylvania
Updated on 7 October 2022
cancer
karnofsky performance status
MRI
glioblastoma multiforme
recurrent glioblastoma
supratentorial glioblastoma multiforme
renal function test
tumor treating fields therapy

Summary

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, Recurrent Glioblastoma, GBM
Treatment Niraparib, Optune, Planned surgical resection
Clinical Study IdentifierNCT04221503
SponsorUniversity of Pennsylvania
Last Modified on7 October 2022

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
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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