NCT01590069

Aerosolized Aldesleukin in Treating Patients With Lung Metastases

Phase I/II Study of Aerosol Interleukin-2 for Pulmonary Metastases

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• 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

Interventions

Type	Name	Description
BIOLOGICAL	Aerosolized Aldesleukin	Breathe aerosolized aldesleukin
OTHER	Laboratory Biomarker Analysis	Optional correlative studies

Timeline

• Start date: 2012-06-28
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2012-05-02
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study