What side effects are associated with this type of intervention?

Common side effects of treatments for pleural tumors, particularly those involving direct chemotherapy delivery and blood supply blockage like Transarterial Chemoembolization (TACE), include localized pain, fever, nausea, vomiting, and fatigue. More severe complications can include infection, liver dysfunction, and post-embolization syndrome, which manifests as abdominal pain, fever, and elevated white blood cell count. There is also a risk of damage to surrounding tissues due to the high concentration of chemotherapy.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments of pleural tumors using methods similar to Transarterial Chemoembolization (TACE). TACE involves the direct delivery of chemotherapy to the tumor and blocking its blood supply, a method primarily used in liver cancer. For pleural tumors, treatments often include systemic chemotherapy, targeted therapy, and immunotherapy. Agents like pemetrexed and cisplatin are commonly used in combination for pleural mesothelioma. While TACE itself is not specifically mentioned for pleural tumors, the concept of localized chemotherapy delivery and blood supply blockage remains an area of ongoing research.

What other types of research exist?

Promising novel alternatives to Transarterial Chemoembolization for pleural tumors in 2024 include: 1) Systemic chemotherapy with agents like pemetrexed and cisplatin, potentially combined with bevacizumab. 2) Immunotherapy options such as nivolumab and ipilimumab, which have shown efficacy in clinical trials. 3) Multimodal approaches, including lung-sparing surgery combined with photodynamic therapy and postoperative chemotherapy. These alternatives offer different mechanisms of action and may provide improved outcomes for patients with pleural tumors.

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Anti-tumor antibiotic

TACE for Lung Cancer

Q: What is the mechanism of action of this treatment?

Transarterial Chemoembolization (TACE) for pleural tumors involves the direct injection of chemotherapy into the tumor's blood supply, followed by the blockage of the artery to trap the drug within the tumor and cut off its blood supply. This dual mechanism ensures a high concentration of chemotherapy in the tumor while depriving it of nutrients and oxygen, leading to tumor cell death. This targeted approach is significant for pleural tumor patients as it may reduce systemic side effects and improve local control of the disease.

Phase 2

Recruiting

Led By Franz E Boas

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Non-small cell lung cancer (any stage), with lung, endobronchial, pleural, or mediastinal tumors that are progressing on systemic therapy (or the patient cannot tolerate systemic therapy), and that are not amenable to resection, thermal ablation, or ablative radiation therapy

Lung-dominant disease (majority of active tumor volume is in the chest)

Must not have

Eastern Cooperative Oncology Group (ECOG) performance status > 2

No measurable treatable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (for example, unable to measure tumor size on CT, or lung nodules are all < 1 cm)

Timeline

Screening 1 week

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a treatment called TACE for patients with non-small cell lung cancer that doesn't respond to other treatments. TACE involves injecting chemotherapy directly into the tumor's blood supply and blocking it, trapping the drugs inside and cutting off nutrients and oxygen to the tumor.

Who is the study for?

Adults with non-small cell lung cancer that's gotten worse on standard treatments or who can't handle those treatments. They should have a majority of their tumor in the chest and not be candidates for surgery, thermal ablation, or ablative radiation. Excluded are pregnant individuals, those with certain heart and lung conditions, severe kidney failure, mental status changes affecting consent/follow-up, specific blood disorders, hyperthyroidism history including subclinical cases, allergies to trial drugs or iodinated contrast that can't be managed premedication.

What is being tested?

The trial is testing transarterial chemoembolization (TACE) for treating non-small cell lung cancer. TACE involves injecting chemotherapy directly into the artery feeding the tumor along with substances to block this artery—trapping chemotherapy within the tumor and cutting off its nutrient supply.

What are the potential side effects?

Possible side effects include pain at injection site; fever; abdominal pain; liver function abnormalities; nausea and vomiting due to chemotherapy; allergic reactions to mitomycin or lipiodol; complications from blocking blood vessels such as tissue damage.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is getting worse despite treatment, and surgery or targeted therapies are not options for me.

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Most of my cancer is located in my chest.

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I am 18 years old or older.

Exclusion Criteria

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

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My daily activity is significantly limited due to my health.

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My cancer cannot be measured using standard scans.

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I have an abnormal connection between the arteries and veins in my lungs.

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I have serious heart failure symptoms.

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I have a heart condition known as left bundle branch block.

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My kidney function is severely reduced.

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My hemoglobin level is below 7, even after a transfusion.

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I have or had an overactive thyroid, including mild cases.

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I am scheduled for radioactive iodine imaging or therapy.

Select...

I am allergic to iodine-based dyes and cannot be treated with standard allergy medications.

Timeline

Screening ~ 1 week1 visit

Treatment ~ Varies

Follow Up ~ 6 months1 visit

Screening ~ 1 week

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 1 week for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events

Local progression free survival

Secondary study objectives

Bronchial versus pulmonary artery blood supply

Growth of TACE targeted lesions versus non-TACE targeted lesions

Lipiodol retention in treated tumors

+3 more

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: Lung chemoembolizationExperimental Treatment5 Interventions

Patients receive lipiodol intra-arterially (IA), mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and computed tomography (CT) at baseline and follow up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Mitomycin

2009

Completed Phase 3

~410

Transarterial Chemoembolization

2009

Completed Phase 1

~100

0 / 13Eligibility 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

Transarterial Chemoembolization (TACE) for pleural tumors involves the direct injection of chemotherapy into the tumor's blood supply, followed by the blockage of the artery to trap the drug within the tumor and cut off its blood supply. This dual mechanism ensures a high concentration of chemotherapy in the tumor while depriving it of nutrients and oxygen, leading to tumor cell death. This targeted approach is significant for pleural tumor patients as it may reduce systemic side effects and improve local control of the disease.

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