Aerosolized Aldesleukin in Treating Patients With Lung Metastases

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Carcinoma, Renal Cell
Melanoma
Metastatic Malignant Neoplasm in the Lung
Metastatic Melanoma
Metastatic Osteosarcoma
Metastatic Renal Cell Cancer
Neoplasms
Osteosarcoma
Sarcoma
Stage IV Cutaneous Melanoma AJCC v6 and v7
Stage IV Osteosarcoma AJCC v7
Stage IV Renal Cell Cancer AJCC v7

Clinical Trial Details

NCT number	NCT01590069
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	June 28, 2012
Completion date	April 30, 2024

View Details

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