Aerosol IL-2 for Pulmonary Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Shannon Wilkes Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01590069
First received: April 30, 2012
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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
Sarcoma
Solid Tumors
Pulmonary Metastases
Lung Metastases
Osteosarcomas
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 [ Time Frame: 2 months minimally, up to 4 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 56
Study Start Date: June 2012
Estimated Primary Completion Date: June 2016 (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

  Eligibility

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

Inclusion Criteria:

  1. Patients with diagnosis of 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 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. No radiotherapy within 2 weeks: Exception: patients may have received palliative low dose radiotherapy to the limbs (30 Gy or less) 1 week before this therapy -provided pelvis, sternum, scapulae, vertebrae, or skull were not included in the radiotherapy field.
  7. Subjects have to be able to read and understand English.
  8. Patients with sarcoma, renal cell carcinoma, or melanoma with known resectable lung metastases.

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 or patients with known disease outside lungs and/or thorax.
  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 ClinicalTrials.gov identifier: NCT01590069

Contacts
Contact: Aung Naing, MD 713-563-0181

Locations
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
Investigators
Principal Investigator: Aung Naing, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01590069     History of Changes
Other Study ID Numbers: 2010-0700, NCI-2012-00788
Study First Received: April 30, 2012
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Sarcoma
Solid Tumors
Pulmonary Metastases
Lung metastases
Osteosarcomas
Ewing sarcoma
IL-2
Interleukin-2
Aldesleukin
Proleukin
Aerosol IL-2
Spirometry
Nebulizer
Pulse oximeter

Additional relevant MeSH terms:
Sarcoma
Neoplasm Metastasis
Neoplasms, Second Primary
Osteosarcoma
Sarcoma, Ewing
Lung Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 02, 2014