Study on Aerosolized Aldesleukin for Treating Lung Metastases
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT01590069
This clinical trial is testing a new treatment using aerosolized aldesleukin to see if it can help treat cancer that has spread to the lungs. The study aims to find the best dose and understand the side effects of this treatment.
Patient Parameters
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Program Overview
This study is exploring the use of aerosolized aldesleukin, a type of biological therapy, to treat patients whose cancer has spread to the lungs. The treatment involves inhaling aldesleukin, which may help the immune system fight cancer by stopping tumor cells from growing. The trial will determine the safest and most effective dose and schedule for this treatment, as well as monitor any side effects.
Description
The main goal of this study is to check for any side effects in patients with lung metastases who are treated with aerosolized aldesleukin. Patients will report their symptoms, and their lung function and oxygen levels will be monitored remotely.
The study will also determine the best dose and schedule for the treatment and see how it affects the immune system. Researchers will measure the levels of aldesleukin in the blood to check for any side effects and evaluate how well the treatment works in shrinking tumors.
Additionally, the study will look at tissue samples from patients who have surgery after the treatment to understand how the therapy affects the cancer.
Patients will receive aerosolized aldesleukin once a day for 21 days, with treatment cycles repeating every 28 days if there are no severe side effects or disease progression. After finishing the treatment, patients will be monitored for 30 days.
Eligibility Criteria
Inclusion Criteria
- Have advanced cancer that has spread to the lungs. Patients with osteosarcoma must have lung metastases.
- Willing to follow the treatment plan and safety checks, including self-reporting symptoms and undergoing tests.
- Have normal kidney and liver function as shown by specific blood tests.
- Have good lung function and oxygen levels without needing extra oxygen.
- Be in good overall health, able to perform daily activities.
- Have recovered from any previous cancer treatments, except for hair loss or hearing loss.
- Have not received radiation therapy within the last two weeks, except for low-dose radiation outside the lungs if needed.
- Be able to read and understand English.
- Have advanced cancer with lung metastases that can be surgically removed.
- Have sarcoma, renal cell carcinoma, or melanoma, or have cancer outside the lungs and chest.
Exclusion Criteria
- Currently using medications like bronchodilators or corticosteroids.
- Pregnant or breastfeeding women, or women of childbearing age not willing to use effective birth control.
- Have uncontrolled health issues, such as infections, heart problems, or mental health conditions that would interfere with the study.
- Have symptoms like fever, cough, shortness of breath, wheezing, or fatigue that are moderate or severe.
- Have lung metastases that cannot be surgically removed.
- Do not have sarcoma, renal cell carcinoma, or melanoma.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| M D Anderson Cancer Center | 77030 | Houston | Texas |
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