Aerosolized Aldesleukin in Treating Patients With Lung Metastases
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ClinicalTrials.gov Identifier: NCT01590069 |
Recruitment Status :
Active, not recruiting
First Posted : May 2, 2012
Last Update Posted : April 28, 2022
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Condition or disease | Intervention/treatment | Phase |
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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 |
PRIMARY OBJECTIVES:
I. To evaluate toxicity in patients with lung metastases during aerosol interleukin (IL)-2 (aldesleukin) therapy using self-report, remote spirometry and pulse oximetry.
SECONDARY OBJECTIVES:
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).
TERTIARY OBJECTIVES:
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.
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 |
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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.
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Biological: Aerosolized Aldesleukin
Breathe aerosolized aldesleukin
Other Name: Aerosolized Recombinant IL-2 Other: Laboratory Biomarker Analysis Optional correlative studies |
- 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.
- 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.
- 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.
- 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.
- 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).

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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

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
United States, Texas | |
M D Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Najat Daw | M.D. Anderson Cancer Center |
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT01590069 |
Other Study ID Numbers: |
2010-0700 NCI-2012-00788 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 0700 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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Melanoma Carcinoma, Renal Cell Neoplasms Osteosarcoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Sarcoma Neoplasms, Connective and Soft Tissue Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Neoplasms, Bone Tissue Neoplasms, Connective Tissue Aldesleukin Antineoplastic Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |