Breathing in a cancer fighter: inhaled IL-2 trial targets lung tumors
NCT ID NCT01590069
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests an inhaled form of interleukin-2 (IL-2), a protein that boosts the immune system, in people whose cancer has spread to the lungs. The goal is to find the best dose and see if it can shrink lung tumors. About 70 adults with cancers like melanoma, sarcoma, or kidney cancer are taking part. The treatment is breathed in through a nebulizer, and researchers monitor side effects and tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- aerosolized interleukin-2 (aldesleukin)
- What this could lead to
- If it works, this could offer a new way to treat lung metastases by boosting the immune system directly in the lungs, potentially controlling tumor growth.
- What could go wrong
- This is an early phase trial with a small number of participants, so the benefits are uncertain. Side effects from immune stimulation may occur, and it may not shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2012
- Expected to finish
-
Apr 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 to 50 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 Exclusion 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
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