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Aerosol IL-2 for Pulmonary Metastases

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ClinicalTrials.gov Identifier: NCT01590069
Recruitment Status : Active, not recruiting
First Posted : May 2, 2012
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Aerosol Interleukin-2 for Pulmonary Metastases
Study Start Date : June 2012
Estimated Primary Completion Date : June 2018


Arms and Interventions

Arm Intervention/treatment
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
  • Aldesleukin
  • 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.


Outcome Measures

Primary Outcome Measures :
  1. 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).

  2. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590069


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Najat Daw-Bitar, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01590069     History of Changes
Other Study ID Numbers: 2010-0700
NCI-2012-00788 ( Registry Identifier: NCI CTRP )
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016

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:
Neoplasm Metastasis
Neoplasms, Second Primary
Sarcoma
Osteosarcoma
Sarcoma, Ewing
Lung Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Aldesleukin
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents