Trial intelligence / Profile preview

Aerosol Interleukin-2 for Pulmonary Metastases

NCT01590069Phase 2

Key facts

Status: Active, not recruiting
Start: Jun 2012
Primary completion: Apr 2029
Countries: 1
Sponsor: University of Texas MD Anderson Cancer Center
Modality: Cytokines & Interferons

Drugs: aldesleukin
Conditions: cancer

Overview

Phase 2, open-label, single-arm trial of aldesleukin in cancer, sponsored by University of Texas MD Anderson Cancer Center. Primary endpoints: Maximum Tolerated Dose at 28 days, Incidence of Adverse Events up to 4 years and 1 more. Started Jun 2012; status: active, not recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Treatment (aerosolized aldesleukin)
Patients receive aerosolized aldesleukin QD on days 1-21. Courses repeat every 28 days.

Who it enrols

Patients with advanced sarcoma, renal cell carcinoma, or melanoma with resectable lung metastases, adequate organ and pulmonary function, and no concurrent use of bronchodilators or corticosteroids.

Endpoints

Primary

Maximum Tolerated Dose28 days
Incidence of Adverse EventsUp to 4 years
Objective Response RateUp to 4 years

Secondary

Interleukin-2 levels in serumDay 1
Changes in biomarker levels8 weeks

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