Aerosol IL-2 for Pulmonary Metastases
This study is currently recruiting participants.
Verified March 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
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: March 4, 2013
Last verified: March 2013
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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:
Genetics Home Reference related topics:
Ewing sarcoma
Drug Information available for:
Aldesleukin
U.S. FDA Resources
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:
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 and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with diagnosis of lung metastases. Patients with no prior therapy are eligible if there is no known superior alternative medical therapy. For phase II expansion cohort diagnosis of sarcoma (Osteosarcomas and Ewing sarcoma family of tumors) lung metastases will be required.
- Willing to comply with protocol therapy and required safety monitoring (self report, pulse oximetry, remote spirometry, labs)
- 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)
- Age 12 or older
- Performance status: ECOG performance status </=1 for ages >/= 16 or Lansky play >/= 80% for ages </= 15
- Patients must have recovered to </= grade 1 toxicity 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.
- Subjects have to be able to read and understand English.
- Patients with sarcoma, renal cell carcinoma, or melanoma with known resectable lung metastases.
Exclusion Criteria:
- Currently being treated with bronchodilators or corticosteroids.
- 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
- 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.
- 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)
- Patients with unresectable lung metastases.
- Patients without sarcoma, renal cell carcinoma, or melanoma or patients with known disease outside lungs and/or thorax.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590069
Contacts
| Contact: Aung Naing, MD | 713-563-0181 |
Locations
| United States, Texas | |
| UT 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 | UT MD 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 |
| Study First Received: | April 30, 2012 |
| Last Updated: | March 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Ewing sarcoma Sarcoma Solid Tumors Pulmonary Metastases Lung metastases Osteosarcomas IL-2 |
Interleukin-2 Aldesleukin Proleukin Aerosol IL-2 Spirometry Nebulizer Pulse oximeter |
Additional relevant MeSH terms:
|
Sarcoma, Ewing's Neoplasm Metastasis Neoplasms, Second Primary Osteosarcoma Lung Neoplasms Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Neoplastic Processes Neoplasms Pathologic Processes Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Aldesleukin Interleukin-2 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013