Aerosolized Aldesleukin in Treating Patients With Lung Metastases

Study summary

This phase I/II trial studies the side effects and best dose of aerosolized aldesleukin and to see how well it works in treating patients with cancer that has spread from the original tumor to the lungs. Biological therapies, such as aerosolized aldesleukin, may stimulate or suppress the immune system in different ways and stop tumor cells from growing.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAerosolized Aldesleukin and Laboratory Biomarker Analysis

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 15, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?M.D. Anderson Cancer Center

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: M.D. Anderson Cancer Center
Interventions being studied: Biological: Aerosolized Aldesleukin; Other: Laboratory Biomarker Analysis

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Patients with diagnosis of advanced cancer with lung metastases; patients with no prior therapy are eligible if there is no known superior alternative medical therapy; for phase Ib expansion cohort diagnosis of osteosarcoma, lung metastases will be required
Willing to comply with protocol therapy and required safety monitoring (self-report, pulse oximetry, remote spirometry, labs)
Creatinine =\< 2 x upper limit of normal (ULN)
Bilirubin =\< 5 x ULN
Aspartate aminotransferase (AST) =\< 5 x ULN
Forced vital capacity (FVC) \>= 50% predicted
Oxygen (O2) saturation at rest \>= 90% (off supplementary oxygen)
Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 for ages \>= 16 or Lansky play \>= 80% for ages =\< 15
Patients must have recovered to =\< grade 1 toxicity (except alopecia and hearing loss) from any prior chemotherapy, other investigational therapy, hormonal, biological, targeted agents
No radiotherapy within 2 weeks: exception: patients may receive palliative low dose radiotherapy (30 Gy or less) for lesions outside the lung at the discretion of the treating physician; palliative radiotherapy could be given before aerosol treatment is started if necessary
Subjects have to be able to read and understand English
Patients with advanced cancer with resectable lung metastases
Patients with sarcoma, renal cell carcinoma, or melanoma or with known disease outside the lungs and/or thorax

Reasons someone may not be able to joinExclusion criteria

Currently being treated with bronchodilators or corticosteroids
Females: pregnant or breast feeding and if of child bearing potential (e.g. female of childbearing age that has not been amenorrheic for at least 12 consecutive month or surgically sterilized) not willing to use effective contraception
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, bradycardia, related to cardiac disease, bundle branch block, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade \>= 2 (Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 4.0)
Patients with unresectable lung metastases
Patients without sarcoma, renal cell carcinoma, or melanoma

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

M D Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 15, 2026. Always confirm current availability with the study team.

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