Aerosol IL-2 for Pulmonary Metastases
|ClinicalTrials.gov Identifier: NCT01590069|
Recruitment Status : Active, not recruiting
First Posted : May 2, 2012
Last Update Posted : January 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma Solid Tumors Pulmonary Metastases Lung Metastases Osteosarcomas Ewing Sarcoma||Drug: Aerosol IL-2 Procedure: Symptom Assessment||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Aerosol Interleukin-2 for Pulmonary Metastases|
|Actual Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
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.
- Response of Measurable Lesions to Aerosol IL-2 (Phase II) [ Time Frame: 2 months minimally, up to 4 months ]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 ]The MTD is defined as the highest dose level with six patients with at most one does limiting toxicity (DLT).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|