Aerosol IL-2 for Pulmonary Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by M.D. Anderson Cancer Center
Shannon Wilkes Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: April 30, 2012
Last updated: October 5, 2015
Last verified: October 2015

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 Intervention Phase
Solid Tumors
Pulmonary Metastases
Lung Metastases
Ewing Sarcoma
Drug: Aerosol IL-2
Procedure: Symptom Assessment
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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).

Estimated Enrollment: 56
Study Start Date: June 2012
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Interleukin-2
  • Aldersleukin
  • Proleukin
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.

  Show Detailed Description


Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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 with lung metastases will be required.
  2. Willing to comply with protocol therapy and required safety monitoring (self report, pulse oximetry, remote spirometry, labs)
  3. Adequate organ function as defined by : renal- creatinine </=2 x upper limit of normal (ULN), hepatic- bilirubin and AST, </=5x ULN; pulmonary: FVC >/=50% predicted, O2 sat at rest >/=90% (off supplementary oxygen)
  4. Age >/=12 and </=50
  5. Performance status: ECOG performance status </=1 for ages >/= 16 or Lansky play >/= 80% for ages </= 15
  6. Patients must have recovered to </= grade 1 toxicity (except alopecia and hearing loss) from any prior chemotherapy, other investigational therapy, hormonal, biological, targeted agents.
  7. 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.
  8. Subjects have to be able to read and understand English.
  9. Patients with advanced cancer with resectable lung metastases.
  10. Patients with sarcoma, renal cell carcinoma, or melanoma or with known disease outside the lungs and/or thorax.

Exclusion Criteria:

  1. Currently being treated with bronchodilators or corticosteroids.
  2. 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
  3. 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.
  4. Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade >/= 2 (CTCAE v4.0)
  5. Patients with unresectable lung metastases.
  6. Patients without sarcoma, renal cell carcinoma, or melanoma.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01590069

Contact: Najat Daw-Bitar, MD 713-792-6620

United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Shannon Wilkes Foundation
Principal Investigator: Najat Daw-Bitar, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01590069     History of Changes
Other Study ID Numbers: 2010-0700, NCI-2012-00788
Study First Received: April 30, 2012
Last Updated: October 5, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Ewing sarcoma
Solid Tumors
Pulmonary Metastases
Lung metastases
Aerosol IL-2
Pulse oximeter

Additional relevant MeSH terms:
Sarcoma, Ewing
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Lung Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplastic Processes
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Analgesics, Non-Narcotic
Antineoplastic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on December 01, 2015