Accession Number : AD1001735

Title :   Phase 0 Trial of Itraconazole for Early-Stage Non-Small Cell Lung Cancer

Descriptive Note : Technical Report,30 Sep 2014,29 Sep 2015

Corporate Author : University of Texas Southwestern Medical Center at Dallas Dallas United States

Personal Author(s) : Gerber,David E

Full Text :

Report Date : 01 Oct 2015

Pagination or Media Count : 10

Abstract : The objective of the proposed project is to determine the biologic effects of the drug itraconazole on lung cancer. Itraconazole is a well tolerated and inexpensive (less than 10% the cost of recently developed molecularly targeted therapies) drug that has been in use for decades to treat fungal infections. Laboratory studies have shown that it also appears to block the growth of cancer through effects on tumor blood vessels (angiogenesis) and by targeting the Hedgehog developmental/survival pathway. In this clinical trial, 15 patients with early-stage lung cancer planned for surgical resection will receive approximately two weeks of itraconazole therapy. Before and during their treatment, they will undergo tissue and blood sampling in addition to magnetic resonance imaging (MRI) scans for biomarker analysis. At the time of surgery, resected tissue will be analyzed for similar biomarkers. These tissue, blood, and imaging biomarkers will be analyzed to determine itraconazole levels, effects on tumor blood vessels, effects on the Hedgehog pathway, and the correlation between each of these endpoints.

Descriptors :   LUNG CANCER , CLINICAL TRIALS , drugs

Distribution Statement : APPROVED FOR PUBLIC RELEASE