What is the mechanism of action of this treatment?

Common treatments for brain tumors include surgery, radiotherapy, chemotherapy, and targeted therapies. Surgery aims to remove as much of the tumor as possible, reducing mass effect and symptoms. Radiotherapy uses high-energy radiation to kill cancer cells and shrink tumors. Chemotherapy, such as temozolomide, disrupts cancer cell division and growth. Targeted therapies, like PARP inhibitors (e.g., niraparib), block specific enzymes involved in DNA repair, making cancer cells more susceptible to damage and death. These treatments are crucial for brain tumor patients as they can improve survival rates and quality of life by targeting the tumor more effectively and reducing recurrence.

What side effects are associated with this type of intervention?

Common treatments for brain tumors, particularly those involving PARP inhibitors like Niraparib, often result in a range of side effects. Hematologic adverse events such as anemia, thrombocytopenia, and neutropenia are frequently observed and can be severe, requiring dose modifications or supportive care. Non-hematologic side effects include nausea, anorexia, and asthenia, which are generally mild to moderate. Other treatments for brain tumors, such as chemotherapy and immunotherapy, can also cause side effects like fatigue, gastrointestinal disturbances, and increased risk of infections. It is crucial for patients to discuss these potential side effects with their healthcare providers to manage them effectively.

What prior FDA approvals exist?

FDA approvals for the treatment of brain tumors have included various chemotherapeutic agents, targeted therapies, and immunotherapies. While specific PARP inhibitors like Niraparib are under investigation for brain tumors, other treatments such as temozolomide, bevacizumab, and tumor-treating fields (TTF) have been approved for glioblastoma. These treatments aim to target tumor growth through different mechanisms, including DNA damage, angiogenesis inhibition, and physical disruption of cancer cell division.

What other types of research exist?

Promising novel alternatives to Niraparib for brain tumor patients include: 1) GD2-CAR T cell therapy for H3K27M-mutated diffuse midline gliomas, 2) ONC201, a selective DRD2 antagonist, for H3 K27M-mutant diffuse midline glioma, 3) Enfortumab Vedotin for urothelial carcinoma after platinum and anti-PD-1/PD-L1 therapy, and 4) Ivosidenib, a mutant-IDH1 inhibitor, for IDH1-mutant gliomas. These therapies have shown potential in clinical trials and may offer new treatment options in 2024.

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PARP Inhibitor

Niraparib for Brain Cancer (OU-SCC-PI-4G Trial)

Phase 2

Waitlist Available

Led By James Battiste, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

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

Must have

Be able to take oral medications

Patients must be ≥ 18 years of age

Must not have

Known active hepatitis B or hepatitis C

Patients have medical risk due to 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing niraparib, a daily capsule, on patients with brain cancer that has returned. Niraparib works by stopping cancer cells from fixing themselves, which may slow down the cancer. Patients will be monitored for several years to see how well they tolerate the treatment and if it helps. Niraparib is approved for use in patients with ovarian cancer.

Who is the study for?

Adults with recurrent high-grade gliomas (GBM, Astrocytoma, Oligodendroglioma) who can take oral meds and have a life expectancy of at least 3 months. They must be stable on corticosteroids if used, not pregnant or breastfeeding, willing to use contraception, and not donate blood during the study. Excludes those with other recent cancers except certain skin cancers, prior PARP inhibitor treatment, active hepatitis B/C or HIV with detectable viral load.

What is being tested?

The trial is testing niraparib's effects on patients with recurrent brain cancer. It aims to understand both positive outcomes and adverse reactions from taking this medication in individuals whose previous treatments for brain tumors have failed.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with niraparib include nausea, fatigue, blood cell count issues which could lead to anemia or infection risks; heart palpitations; constipation; muscle and joint pain.

Eligibility Criteria

Inclusion Criteria

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

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I can take pills by mouth.

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I am 18 years old or older.

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My high-grade brain tumor has come back, confirmed by MRI or surgery.

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I can provide a sample of my tumor for testing, or I have one already.

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My blood pressure is under control, below 140/90 mmHg.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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I have an active hepatitis B or C infection.

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I have a serious health condition that is not under control.

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I have a history of MDS or AML.

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I haven't had significant radiation therapy affecting my bone marrow recently.

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I have been treated with a PARP inhibitor before.

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I have serious stomach or bowel issues that affect how my body absorbs medicine.

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I am not allergic to niraparib or its ingredients like lactose monohydrate and magnesium stearate.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Efficacy of Treatment in Dose Expansion Phase

Number of Patients Who Experience Adverse Events

Number of Patients Who Experience Toxicities With Individualized Starting Dose (ISD) of Niraparib Using CTCAE v5.0

Secondary study objectives

Duration of Disease Control of All Patients

Overall Survival in Dose Expansion Phase

Progression Free Survival in Dose Expansion Phase

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%

Abdominal pain

22%

Dizziness

22%

Insomnia

22%

Dyspnea

17%

Platelet count decreased

17%

Headache

17%

Mucositis oral

17%

Creatinine increased

13%

Vomiting

13%

Rash maculo-papular

13%

Aspartate aminotransferase increased

13%

Sinus tachycardia

Cough

Dehydration

Urinary tract infection

Dry mouth

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Upper respiratory infection

Hoarseness

Hypotension

Hot flashes

Head injury

Hypokalemia

Hyponatremia

Flu like symptoms

Hyperglycemia

Neutrophil count decreased

Tremor

Diarrhea

Depression

Itchy eyes

Oral petechia

Edema limbs

Bruising

Esophageal ulcer

Hyperkalemia

Peripheral sensory neuropathy

Leukocytosis

White blood cell decreased

Postnasal drip

Skin tear

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

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Niraparib TreatmentExperimental Treatment1 Intervention

Patients will be treated with individualized starting dose of Niraparib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

2018

Completed Phase 4

~2400

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

Common treatments for brain tumors include surgery, radiotherapy, chemotherapy, and targeted therapies. Surgery aims to remove as much of the tumor as possible, reducing mass effect and symptoms. Radiotherapy uses high-energy radiation to kill cancer cells and shrink tumors. Chemotherapy, such as temozolomide, disrupts cancer cell division and growth. Targeted therapies, like PARP inhibitors (e.g., niraparib), block specific enzymes involved in DNA repair, making cancer cells more susceptible to damage and death. These treatments are crucial for brain tumor patients as they can improve survival rates and quality of life by targeting the tumor more effectively and reducing recurrence.

Combining PARP inhibitors with radiation therapy for the treatment of glioblastoma: Is PTEN predictive of response?Advances in the biology of astrocytomas.