What side effects are associated with this type of intervention?

Common treatments for brain cancer include surgery, radiation therapy, and chemotherapy. Side effects of these treatments can vary but often include fatigue, nausea, vomiting, hair loss, and cognitive changes. For treatments similar to Niraparib, which is a PARP inhibitor, side effects may include hematologic toxicities such as anemia, neutropenia, and thrombocytopenia, as well as gastrointestinal issues like nausea and vomiting. Additionally, patients may experience fatigue and potential liver function abnormalities.

What prior FDA approvals exist?

The FDA has approved several treatments for brain cancer, including temozolomide, bevacizumab, and lomustine. Temozolomide is an oral chemotherapy drug commonly used for glioblastoma. Bevacizumab, an anti-angiogenic drug, is used for recurrent glioblastoma. Lomustine, an alkylating agent, is also used for high-grade gliomas. While PARP inhibitors like Niraparib are being studied for their efficacy in brain cancers, they are not yet FDA-approved for this indication. Current research is exploring their potential, particularly in tumors with specific genetic mutations.

What other types of research exist?

Promising novel alternatives to Niraparib for brain cancer patients include: 1) Tumor-Treating Fields (TTF) combined with Temozolomide, which has shown efficacy in glioblastoma treatment. 2) Pembrolizumab and Nivolumab, which are immune checkpoint inhibitors being explored for recurrent glioblastoma. 3) Bevacizumab, an angiogenesis inhibitor, which has shown some benefit in recurrent meningiomas. 4) Lenvatinib plus Pembrolizumab, which has demonstrated improved progression-free survival in other cancers and may be considered for brain cancer.

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PARP Inhibitor

Niraparib for Brain Cancer

Phase 2

Recruiting

Led By Priscilla Brastianos, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Diagnosis of triple negative breast cancer or ovarian cancer, or any cancer histology with the presence of alteration in BRCA1, BRCA2, PARP metabolism, DNA repair pathways and HRD (homologous recombination deficiency) genes in the metastatic site as described in Section 9.2 using a CLIA-certified assay

Tissue from a prior craniotomy or biopsy for clinical genetic sequencing

Must not have

Participant has had radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy

Prior treatment with PARP inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing niraparib, a drug that may help treat cancer that has spread to the brain and spinal cord. It works by preventing cancer cells from fixing their damaged DNA, which can help kill them. The study will include about 20 participants and will last for a significant period. Niraparib is an oral drug approved for maintenance treatment in various cancers including ovarian cancer.

Who is the study for?

This trial is for adults with solid tumors that have spread to the brain and are minimally symptomatic. Participants must have measurable CNS disease, be stable on medications, and not have had recent major surgery or blood transfusions. They should not have been treated with PARP inhibitors before and must not be pregnant or breastfeeding. A good performance status and normal organ function are required.

What is being tested?

The effectiveness of niraparib, a drug designed to combat cancer in the central nervous system (CNS), is being tested. The study focuses on patients whose cancer has metastasized to the CNS, particularly those with genetic alterations related to DNA repair pathways.

What are the potential side effects?

Niraparib may cause side effects such as fatigue, low blood cell counts leading to increased infection risk or bleeding problems, nausea, constipation or diarrhea, heart palpitations, insomnia, dizziness and dry mouth.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is triple negative or has specific genetic changes.

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I have had brain surgery or a biopsy for genetic testing.

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My organ and bone marrow functions are normal.

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I am older than 18 years.

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I can care for myself but may not be able to do active work.

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My brain or spinal cord cancer is getting worse.

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My cancer diagnosis was confirmed through tissue or cell analysis.

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I have a brain lesion that is at least 10 mm big.

Exclusion Criteria

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

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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 do not have any serious, uncontrolled illnesses or infections.

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I have never had myelodysplastic syndrome or acute myeloid leukemia.

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I haven't had chemotherapy, immunotherapy, or radiotherapy in the last 2 weeks and have no ongoing major side effects from previous treatments.

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

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I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Intracranial Clinical benefit rate

Secondary study objectives

Extracranial clinical benefit rate

Extracranial disease progression

Intracranial disease progression

+2 more

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%

Rash maculo-papular

13%

Vomiting

13%

Aspartate aminotransferase increased

13%

Sinus tachycardia

Dehydration

Cough

Urinary tract infection

Dry mouth

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Upper respiratory infection

Hoarseness

Hypotension

Postnasal drip

Head injury

Hypokalemia

Hyponatremia

Flu like symptoms

Hyperglycemia

Neutrophil count decreased

Tremor

Hot flashes

Diarrhea

Depression

Itchy eyes

Edema limbs

Bruising

Esophageal ulcer

Hyperkalemia

Peripheral sensory neuropathy

Leukocytosis

White blood cell decreased

Skin tear

Oral petechia

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: NiraparibExperimental Treatment1 Intervention

Participants will receive niraparib 1x daily for each 28 day study treatment cycle up to 2 years or until disease worsens or unacceptable side effects occur.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

2018

Completed Phase 4

~2400

0 / 15Eligibility 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

The most common treatments for brain cancer include surgery, radiation therapy, chemotherapy, and targeted therapies. Targeted therapies, such as PARP inhibitors like Niraparib, work by exploiting specific genetic weaknesses in cancer cells. PARP inhibitors block the PARP enzyme, which is crucial for repairing DNA damage in cells. Cancer cells, particularly those with existing DNA repair defects, rely heavily on PARP for survival. By inhibiting PARP, these drugs cause the accumulation of DNA damage, leading to cancer cell death. This mechanism is particularly important for brain cancer patients as it offers a more precise treatment option that can potentially improve outcomes and reduce side effects compared to traditional therapies.

Applied Precision Cancer Medicine in Neuro-Oncology.