Study on Niraparib and Tumor-Treating Fields for Recurrent Glioblastoma

Sponsor: Abramson Cancer Center at Penn Medicine

Sponsor score: 0

ClinicalTrials ID:NCT04221503

Provider View

This clinical trial is testing the combination of niraparib, a PARP inhibitor, and Tumor-Treating Fields (TTFields) to see if they can effectively treat glioblastoma that has returned after initial treatment.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of using niraparib, a drug that blocks DNA repair in cancer cells, together with Tumor-Treating Fields (TTFields), a therapy that uses electric fields to disrupt cancer cell growth. This combination is being tested in patients with glioblastoma, a type of brain cancer, that has come back after previous treatment. Researchers believe that TTFields may make the cancer cells more sensitive to niraparib, potentially leading to better treatment outcomes.

Description

This study is exploring a new treatment approach for recurrent glioblastoma, a type of brain cancer. The treatment combines niraparib, a drug that inhibits a specific DNA repair process in cancer cells, with Tumor-Treating Fields (TTFields), which use electric fields to interfere with cancer cell division. The hypothesis is that TTFields will make the cancer cells more vulnerable to niraparib, leading to increased cancer cell death. Participants will receive this combination therapy to assess its safety and effectiveness in controlling the cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with glioblastoma that has returned after radiation therapy.
  • Tumor must have a specific genetic marker (MGMT methylation status) available from previous tests.
  • Must have a measurable tumor by MRI scan within 28 days before starting the study.
  • Can have had multiple previous treatments for glioblastoma.
  • Must have recovered from severe side effects of previous treatments.
  • Able to swallow pills.
  • Have a Karnofsky performance status of 60 or higher, indicating the ability to care for oneself with some assistance.
  • Expected to live more than 3 months.
  • Have adequate blood, liver, and kidney function based on recent tests.
  • Women must have a negative pregnancy test, and both men and women must agree to use effective birth control.
  • Agree not to donate blood during the study and for 90 days after the last dose of niraparib.
  • Must be able to use the Optune device, which delivers TTFields.
  • For surgical patients: Must be undergoing surgery and have available tumor tissue from a previous surgery.
  • Must understand and agree to participate in the study by signing a consent form.

Exclusion Criteria

  • Under 22 years old.
  • Have used Tumor-Treating Fields therapy in the past 6 months.
  • Have used a PARP inhibitor before.
  • Have a history or current diagnosis of certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
  • Have a tumor located in the lower part of the brain (infratentorial tumor).
  • Have had severe blood-related side effects from previous chemotherapy that lasted more than 4 weeks.
  • Have serious, uncontrolled medical conditions or infections.
  • Have implanted electronic devices in the brain, like pacemakers or stimulators (non-programmable shunts are allowed).
  • Have skull defects.
  • Have allergies to the study treatment components.
  • Have digestive issues that affect medication absorption.
  • Are prisoners or involuntarily incarcerated.
  • Are detained for psychiatric or infectious disease treatment.
  • Are participating in another clinical trial.

Locations

FACILITYZIPCITYSTATE
Hospital of the University of Pennsylvania19104PhiladelphiaPennsylvania

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