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Aerosolized Aldesleukin in Treating Patients With Lung Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01590069
Recruitment Status : Active, not recruiting
First Posted : May 2, 2012
Last Update Posted : April 28, 2022
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase I/II trial studies the side effects and best dose of aerosolized aldesleukin and to see how well it works in treating patients with cancer that has spread from the original tumor to the lungs. Biological therapies, such as aerosolized aldesleukin, may stimulate or suppress the immune system in different ways and stop tumor cells from growing.

Condition or disease Intervention/treatment Phase
Metastatic Malignant Neoplasm in the Lung Metastatic Melanoma Metastatic Osteosarcoma Metastatic Renal Cell Cancer Sarcoma Stage IV Cutaneous Melanoma AJCC v6 and v7 Stage IV Osteosarcoma AJCC v7 Stage IV Renal Cell Cancer AJCC v7 Biological: Aerosolized Aldesleukin Other: Laboratory Biomarker Analysis Phase 1

Detailed Description:


I. To evaluate toxicity in patients with lung metastases during aerosol interleukin (IL)-2 (aldesleukin) therapy using self-report, remote spirometry and pulse oximetry.


I. To determine dose and schedule of an acceptable aerosol IL-2 regimen and correlate with absolute lymphocyte count (ALC).

II. To determine serum IL-2 levels on day 1 of therapy for evidence of spillover into circulation and correlate with absence or presence of toxicity.

III. To evaluate the efficacy of aerosol IL-2 treatment using Response Evaluation Criteria in Solid Tumors (RECIST).


I. To evaluate the histology in post-surgical specimens in patients who undergo surgery for lung metastases following aerosol IL-2 treatment as an optional procedure.

II. To evaluate immune correlates from optional pre-treatment biopsy and post-surgical specimen.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive aerosolized aldesleukin once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression of unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
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
Actual Study Start Date : June 28, 2012
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Treatment (aerosolized aldesleukin)
Patients receive aerosolized aldesleukin QD on days 1-21. Courses repeat every 28 days in the absence of disease progression of unacceptable toxicity.
Biological: Aerosolized Aldesleukin
Breathe aerosolized aldesleukin
Other Name: Aerosolized Recombinant IL-2

Other: Laboratory Biomarker Analysis
Optional correlative studies

Primary Outcome Measures :
  1. Maximum tolerated dose, defined as the highest dose level with six patients with at most one dose limiting toxicity, using the CTCAE v4.0 (Phase I) [ Time Frame: 28 days ]
    The dose escalation will be conducted via the accelerated titration method for the first 2 dose levels.

  2. Incidence of adverse events (AE)s, using the CTCAE v4.0 (Phase II) [ Time Frame: Up to 4 years ]
    AEs will be summarized by severity according to the worst grade experienced over the number of patients at risk.

  3. Response of measurable lesions to aerosol aldesleukin using modified RECIST (Phase II) [ Time Frame: Up to 4 years ]
    Response analysis will be performed on intent-to-treat, that is, any patient who enrolled into the expansion cohort. Patients who withdraw before the end of 2 months without responding will be considered non-responders. The two-sided 95% Clopper-Pearson confidence intervals will be calculated for the proportion of patients with responses.

Secondary Outcome Measures :
  1. IL-2 levels in serum [ Time Frame: Day 1 of therapy ]
    Serum IL-2 levels will be compared with maximum grade of toxicity to determine whether our hypothesis of "spillover" of IL-2 in the circulation - i.e. some escaping the receptor gauntlet of IL-2 receptor bearing cells in pulmonary lymphatics.

  2. Changes in biomarker levels [ Time Frame: Baseline to 8 weeks ]
    Changes in biomarker levels between pre- and post-treatment tissue samples will be assessed using paired t-tests (if the data are normally distributed) or Wilcoxon signed-rank tests (otherwise). Will graph the data using histograms, box plots and dot plots. With 20 patients, using a 2-sided 5% alpha, there would be 80% power to detect an effect size of 0.66 (where the effect size is the mean difference divided by the standard deviation of the differences).

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • 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, lung metastases will be required
  • Willing to comply with protocol therapy and required safety monitoring (self-report, pulse oximetry, remote spirometry, labs)
  • Creatinine =< 2 x upper limit of normal (ULN)
  • Bilirubin =< 5 x ULN
  • Aspartate aminotransferase (AST) =< 5 x ULN
  • Forced vital capacity (FVC) >= 50% predicted
  • Oxygen (O2) saturation at rest >= 90% (off supplementary oxygen)
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1 for ages >= 16 or Lansky play >= 80% for ages =< 15
  • 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 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
  • Subjects have to be able to read and understand English
  • Patients with advanced cancer with resectable lung metastases
  • Patients with sarcoma, renal cell carcinoma, or melanoma or with known disease outside the lungs and/or thorax

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 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0)
  • Patients with unresectable lung metastases
  • Patients without sarcoma, renal cell carcinoma, or melanoma

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 identifier (NCT number): NCT01590069

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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Najat Daw M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01590069    
Other Study ID Numbers: 2010-0700
NCI-2012-00788 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2010-0700 ( Other Identifier: M D Anderson Cancer Center )
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue
Neoplasms, Glandular and Epithelial
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents