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 : December 8, 2020
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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, 2021|
|Estimated Study Completion Date :||December 31, 2022|
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
- 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).
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|