NCT02009436

Azacitidine in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer

Phase I Study of Inhaled Vidaza® in Patients With Advanced NSCLC

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase I trial studies the side effects and best dose of azacitidine in treating patients with lung cancer that is stage IV or has returned after previous treatments (recurrent). Azacitidine is a drug used in chemotherapy that may stop tumor cells from growing or spreading by activating genes that help prevent cancer growth, called tumor suppressor genes. As people age, these genes are silenced by a chemical reaction that occurs naturally in the body, or by exposure to environmental factors such as smoking. Azacitidine may help reverse this process and restore the function of the tumor suppressor genes. Delivering azacitidine directly into the lungs by inhalation may work better in treating lung cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and toxicity of inhaled Vidaza® (azacitidine) with special emphasis on pulmonary toxicity. SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetics of inhaled Vidaza®. II. To determine the changes in global methylation patterns in the bronchial epithelium (bronchial tissue samples) pre and post treatment. III. To determine the changes in methylation patterns in the exhaled breath. IV. To evaluate the efficacy of inhaled Vidaza® on intra-thoracic tumors (response rate by Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria for intrapulmonary lesions). V. To estimate the progression free, intra-thoracic tumor progression free and overall survival. VI. To determine the minimum effective dose of inhaled Vidaza® required to induce changes in the methylation status and re-expression of a panel of genes, including 5 candidate tumor suppressor genes (cyclin-dependent kinase inhibitor 2A \[p16\], h-cadherin \[H-Cad\], opioid binding protein/cell adhesion molecule-like \[OPCML\], secreted frizzled-related protein 1 \[SFRP-1\], and ras association domain family 1 \[RASSF1A\]) that are silenced in 20-50% of bronchial tissue of heavy smokers with lung cancer. OUTLINE: This is a dose-escalation study. Patients receive azacitidine via nebulizer over 20 minutes once daily (QD) on days 1-5 and 15-19. Treatment repeats every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients may continue treatment on a case-by-case basis at the discretion of principal investigator and Institutional Review Board. After completion of study treatment, patients are followed up at 4-6 weeks and then every 3 months thereafter.

Conditions

• Recurrent Non-Small Cell Lung Carcinoma
• Stage IV Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Azacitidine	Given via nebulizer
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2015-02-09
• Primary completion: 2018-07-18
• Completion: 2018-07-18
• First posted: 2013-12-12
• Last updated: 2020-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study