What side effects are associated with this type of intervention?

Common treatments for sarcoma, such as the use of cisplatin in pulmonary suffusion, are associated with several side effects. Cisplatin can cause nephrotoxicity, ototoxicity, neurotoxicity, gastrointestinal issues, and myelosuppression. While localized delivery methods like pulmonary suffusion aim to minimize systemic side effects, they can still result in local tissue damage and inflammation.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of sarcoma, including pazopanib, which is used for advanced soft tissue sarcoma after prior chemotherapy. Pazopanib targets vascular endothelial growth factor (VEGF) and has shown efficacy in prolonging progression-free survival. Additionally, cisplatin, a chemotherapeutic agent used in pulmonary suffusion, is commonly employed in various sarcoma treatment regimens. While pulmonary suffusion itself is still under investigation, the use of cisplatin and similar agents in sarcoma treatment is well-established.

What other types of research exist?

Promising novel alternatives to pulmonary suffusion for sarcoma patients include: 1) Aerosolized chemotherapy, such as aerosolized gemcitabine, which has shown feasibility and safety in treating lung metastases. 2) Antifibrotic agents, which are being explored for their potential to modify the extracellular environment and suppress lung metastasis of osteosarcoma. 3) Personalized, genotype-directed therapies, such as RET inhibitors (selpercatinib and pralsetinib) for specific genetic mutations, though primarily used in non-small cell lung cancer, they represent a growing field of targeted therapy that could be adapted for sarcoma.

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Alkylating agents

Pulmonary Suffusion for Lung Metastases

Phase 1 & 2

Recruiting

Led By Todd L Demmy

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

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

Must have

Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

Six minute walk >= 50 % of the expected distance

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac conditions ( ike congestive heart failure, angina pectoris, and arrhythmias that are unstable or refractory to management) or psychiatric illness/social situations that would limit compliance with study requirements

Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a method called pulmonary suffusion, which delivers chemotherapy directly to lung tissues. It targets patients with sarcoma or colorectal cancer that has spread to the lungs. The goal is to kill cancer cells more effectively and reduce side effects by focusing treatment on the lungs.

Who is the study for?

This trial is for patients with sarcoma or colorectal cancer that has spread to the lungs, who can undergo a special procedure called pulmonary suffusion. They must have controlled primary tumors, be able to walk a certain distance, and not need home oxygen. Participants should agree to use contraception and not be pregnant.

What is being tested?

The study tests pulmonary suffusion—a way of delivering chemotherapy directly into lung tissue—to control minimal residual disease in lung metastases from sarcoma or colorectal cancer. Cisplatin is the chemotherapeutic agent used in this minimally invasive technique.

What are the potential side effects?

Possible side effects include reactions related to cisplatin such as nausea, vomiting, kidney damage, hearing loss, nerve problems like numbness or tingling sensations (neuropathy), and an increased risk of infection due to lowered blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

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I am able to get out of my bed or chair and move around.

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I can walk at least half the distance expected for someone my age and size in six minutes.

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My oxygen levels stay above 88% whether I'm moving or resting.

Exclusion Criteria

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

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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

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I do not have brain metastases.

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My lung cancer spread cannot be fully removed or treated with surgery.

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I have severe nerve pain or numbness in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Incidence of local toxicities (Phase I)

Local recurrence (Phase II)

Secondary study objectives

Disease-free survival (Phase II)

Incidence of local and systemic toxicities (Phase I)

Incidence of local and systemic toxicities (Phase II)

+1 more

Other study objectives

Immune markers (Phase II)

Lung injury (% reduction of spirometry and differential reduction by quantitative perfusion scan) (Phase II)

Overall survival (Phase II)

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: Prevention (cisplatin, metastasectomy)Experimental Treatment3 Interventions

Patients undergo pulmonary suffusion consisting of cisplatin via infusion. Patients the undergo metastasectomy. Beginning 4-8 weeks, patients with unresectable sarcoma may receive chemotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Metastasectomy

2010

N/A

~100

0 / 7Eligibility 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 Sarcoma include chemotherapy, radiation therapy, and surgical resection. Chemotherapy, such as the use of cisplatin in Pulmonary Suffusion, works by killing tumor cells, stopping them from dividing, or preventing them from spreading. Radiation therapy uses high-energy rays to target and destroy cancer cells, while surgical resection involves the physical removal of the tumor. These treatments are crucial for Sarcoma patients as they aim to reduce tumor size, control local and distant disease spread, and improve survival rates. The minimally invasive approach of Pulmonary Suffusion, which delivers chemotherapy directly to lung tissues, is particularly significant as it may enhance drug efficacy and reduce systemic side effects, offering a promising option for patients with lung metastases.

Experience with the management of primary endodermal sinus tumor of the mediastinum.Case Analysis of 14 Children with Malignant Rhabdoid Tumor of the Kidney.[A case of gastric cancer treated with chemotherapy with weekly paclitaxel and expandable metallic stent placement that resulted in long-term quality of life].