Aerosol IL-2 for Pulmonary Metastases
The goal of this clinical research study is find the highest tolerable dose of interleukin-2 (IL-2) that can be given as an inhaled mist to patients with lung metastases. The safety of this drug using this administration will also be studied.
IL-2 is a protein that triggers white blood cells, called natural killer cells or T-cells, to kill cancer cells. When given as a shot or by vein, IL-2 has been known to cause fevers and flu-like side effects, including rashes, fatigue, and extra fluid in the skin or lungs. These symptoms are less when IL-2 is inhaled as a mist into your body.
Drug: Aerosol IL-2
Procedure: Symptom Assessment
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Aerosol Interleukin-2 for Pulmonary Metastases|
- Response of Measurable Lesions to Aerosol IL-2 (Phase II) [ Time Frame: 2 months minimally, up to 4 months ] [ Designated as safety issue: No ]The number of participants with a response to aerosol IL-2. Response defined as complete response (CR) or partial response (PR) at the end of 2 months period, or stable disease (SD) that lasts for more than 4 months. Clinical response assessed by Chest CT and determined using modified RECIST criteria after the 2nd cycle of aerosol IL-2 (i.e. week 7 or 8).
- Maximum Tolerated Dose Level (MTD) (Phase I) [ Time Frame: First 21 day cycle ] [ Designated as safety issue: Yes ]The MTD is defined as the highest dose level with six patients with at most one does limiting toxicity (DLT).
|Study Start Date:||June 2012|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Experimental: Aerosol IL-2
Aerosol IL-2 starting 1 mg in 3 mL volume of nebulized solution daily for 21 days of a 28 day cycle. Symptom Assessment (self report), oximetry, and pulmonary function assessed prior to each nebulized dose of IL-2 using remote spirometry and pulse oximetry.
Drug: Aerosol IL-2
Phase I starting dose: 1 mg in 3 mL volume of nebulized solution daily for 21 days of a 28 day cycle.
Phase II starting dose: Maximum tolerated dose from Phase I.
Other Names:Procedure: Symptom Assessment
Symptoms (self report), oximetry, and pulmonary function assessed prior to each nebulized dose of IL-2 using remote spirometry and pulse oximetry.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01590069
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Najat Daw-Bitar, MD||M.D. Anderson Cancer Center|