What side effects are associated with this type of intervention?

Common treatments for Glioblastoma, such as PARP inhibitors like Niraparib and Tumor-Treating Fields (TTFields), have specific side effects. PARP inhibitors often cause hematologic issues like anemia, thrombocytopenia, and neutropenia, along with nausea, anorexia, and asthenia. TTFields typically result in skin irritation, discomfort at the application site, and headaches. Combining these treatments can lead to overlapping toxicities, particularly cytopenias, necessitating careful management.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including Temozolomide, an oral alkylating agent, and Tumor-Treating Fields (TTFields), a device that uses electric fields to disrupt cell division. While Niraparib, a PARP inhibitor, is being studied for its efficacy in Glioblastoma, it has not yet received FDA approval for this indication. TTFields, marketed as Optune, is specifically approved for Glioblastoma and represents a novel approach by using alternating electric fields to inhibit tumor growth.

What other types of research exist?

Promising novel alternatives for glioblastoma treatment in 2024 include: 1) Ivosidenib, a mutant-IDH1 inhibitor, which has shown efficacy in IDH1-mutant gliomas. 2) Vorasidenib, a dual mutant-IDH1/2 inhibitor, currently in phase III trials. 3) Bevacizumab, an angiogenesis inhibitor, which has shown some efficacy in recurrent glioblastomas. 4) Immunotherapies such as PD-1 blockade with nivolumab, which has shown activity in recurrent high-grade gliomas. These alternatives offer different mechanisms of action and may provide new hope for glioblastoma patients.

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PARP Inhibitor

Niraparib + Optune for Glioblastoma

Phase 2

Waitlist Available

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be able to swallow oral medications

Karnofsky performance status >= 60

Must not have

Skull defects

Patients with infratentorial tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up when termination of the study or 5 years after removal from protocol therapy, whichever occurs first.

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests niraparib and TTFields in patients with recurrent glioblastoma. The electric fields weaken the cancer cells, and the drug stops them from fixing themselves, leading to cell death. Tumor-Treating Fields (TTFields) is a noninvasive cancer treatment that uses low-intensity alternating electric fields to disrupt cell division and has been FDA-approved for glioblastoma.

Who is the study for?

This trial is for adults over 22 with recurrent glioblastoma after radiation therapy. They must understand and consent to the study, have measurable disease by MRI, be in stable health with a life expectancy over 3 months, and agree to contraception. Excluded are those with certain blood disorders, prior Optune use within 6 months, hypersensitivity to treatment components or severe medical conditions.

What is being tested?

The trial tests niraparib's effectiveness combined with Tumor-Treating Fields (TTFields) on recurrent glioblastoma. It includes patients who've had multiple relapses and measures safety alongside efficacy of this combination therapy.

What are the potential side effects?

Potential side effects include blood-related issues like anemia or thrombocytopenia from niraparib; skin irritation or discomfort from TTFields device; as well as general drug-related reactions such as fatigue, nausea, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow pills.

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I can care for myself but may need occasional help.

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My brain tumor's MGMT methylation status is known from a previous test.

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My glioblastoma has returned after radiation treatment.

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My kidney function is good as tested within the last week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a defect in my skull.

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My tumor is located in the lower part of my brain.

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I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.

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I do not have any serious health issues that are not under control.

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I am allergic to certain gel materials or ingredients in niraparib.

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I am younger than 22 years old.

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I have or had myelodysplastic syndrome or acute myeloid leukemia.

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I do not have stomach or intestine problems affecting medicine absorption.

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I have been treated with a PARP inhibitor before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ when termination of the study or 5 years after removal from protocol therapy, whichever occurs first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~when termination of the study or 5 years after removal from protocol therapy, whichever occurs first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and when termination of the study or 5 years after removal from protocol therapy, whichever occurs first. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease control, defined as achievement of either CR, PR, or SD, as defined by modified Response Assessment in Neuro-Oncology (mRANO) criteria.

Secondary study objectives

Duration of disease control.

Number of AEs (Adverse Events)

Objective radiographic response (ORR)

+2 more

Other study objectives

Objective response rate (ORR) associations.

Overall survival (OS) associations

Progression-free survival (PFS) associations

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347

74%

Fatigue

52%

Nausea

39%

Constipation

39%

Anorexia

30%

Anemia

30%

Alkaline phosphatase increased

26%

Weight loss

22%

Dizziness

22%

Insomnia

22%

Dyspnea

22%

Abdominal pain

17%

Headache

17%

Mucositis oral

17%

Platelet count decreased

17%

Creatinine increased

13%

Vomiting

13%

Rash maculo-papular

13%

Aspartate aminotransferase increased

13%

Sinus tachycardia

Urinary tract infection

Cough

Dehydration

Dry mouth

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Hoarseness

Hypotension

Peripheral sensory neuropathy

Hyperkalemia

Head injury

Hypokalemia

Hyponatremia

Bruising

Postnasal drip

Flu like symptoms

Skin tear

Hyperglycemia

Neutrophil count decreased

Tremor

Esophageal ulcer

Hot flashes

Diarrhea

Depression

Itchy eyes

Oral petechia

Edema limbs

Upper respiratory infection

Leukocytosis

White blood cell decreased

Lung infection

Bloating

Unknown infection

Hematuria

Ascites

Sinus pain

Sore throat

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

Cohort B

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cohort AExperimental Treatment2 Interventions

Cohort A is for subjects with recurrent glioblastoma who do not have clinical indication for surgical resection of the recurrent tumor. Subjects in Cohort A will initiate and continue TTFields therapy for 5-7 days prior to starting niraparib.

Group II: Cohort BActive Control3 Interventions

Cohort B is for subjects with recurrent glioblastoma who have a clinical indication for surgical resection of the recurrent tumor. Subjects in Cohort B will receive TTFields for 5-7 days prior to planned surgical resection, undergo surgical resection, resume TTFields postoperatively, and initiate niraparib 5- 7 days after starting TTFields postoperatively.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Optune

2016

Completed Phase 1

~90

Niraparib

FDA approved

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Niraparib, a PARP inhibitor, blocks the PARP enzyme essential for repairing single-strand DNA breaks, causing cancer cell death due to accumulated DNA damage. Tumor-Treating Fields (TTFields) use alternating electric fields to disrupt cell division by interfering with mitotic spindle formation, leading to apoptosis. These treatments are significant for Glioblastoma patients as they target the cancer cells' repair and division mechanisms, potentially improving treatment efficacy.