Neoadjuvant Itraconazole in Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02357836|
Recruitment Status : Recruiting
First Posted : February 6, 2015
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Itraconazole||Early Phase 1|
This is a phase 0 clinical trial. While clinical data including safety will be recorded, the principal outcomes are pharmacodynamic endpoints. Specifically, the investigators seek to identify: (1) effects of itraconazole on tumor angiogenesis, (2) effects of itraconazole on the Hh pathway, (3) biomarker predictors of these effects, (4) the correlation between itraconazole pharmacokinetics and these effects, (5) the correlation between different biomarkers.
Up to 15 eligible patients with previously diagnosed or suspected NSCLC planned for resection will undergo a study-specific core needle biopsy, imaging (dynamic contrast enhanced [DCE]-, diffusion weighted imaging [DWI]-, and arterial spin labeling [ASL] magnetic resonance imaging [MRI]), skin punch biopsy, and collection of peripheral blood. Subjects will then receive itraconazole 600 mg PO daily for 7-10 days, following which they will undergo repeat imaging, skin biopsy, and blood collection. Subsequently they will undergo surgical resection. Due to the safety profile of itraconazole when used as an antifungal agent , all histologic subtypes of NSCLC will be eligible for the trial. The itraconazole dose of 600 mg, higher than an anti-angiogenic dose, has been shown to inhibit the Hedgehog (Hh) pathway.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 0 Pharmacodynamic Study of the Effects of Itraconazole on Tumor Angiogenesis and the Hedgehog Pathway in Early-stage Non-small Cell Lung Cancer|
|Actual Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
600 mg twice daily for 10-14 days
Once on study, itraconazole will be taken twice daily for a total of 10-14 days. After being on itraconazole for 7-10 days, "Post-treatment" assessments will include a skin biopsy, blood draw for the PK analyses and the cytokine panel, and also MRI evaluations (anticipated to last 45-50 minutes). Toxicity assessments and laboratory checks will also be conducted during that time. Following these assessments, itraconazole will be continued until the day of surgery. At the time of surgical resection, a tissue sample (with adjacent normal tissue as per standard resection technique) will be obtained to complete the analysis. Following resection, subjects will be followed per standard post-operative procedure.
- Change in Pharmacodynamics (assessed by changes in tumor tissue microvessel density [MVD]) [ Time Frame: Tumor Tissue will be collected: 1-Baseline prior to treatment 2-And Post Treatment (after 7-10 days of itraconazole bid) ]Determine the pharmacodynamic effects of itraconazole on tumor angiogenesis (assessed by changes in tumor tissue microvessel density [MVD])
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357836
|Contact: Jessica Saltarski, BS, CCRP||214-648-7097||Jessica.Saltarski@utsouthwestern.edu|
|Contact: David Gerber, M.D.||214-648-4180||David.Gerber@utsouthwestern.edu|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Jessica Saltarski, B.S., CCRP 214-648-7097 Jessica.Saltarski@utsouthwestern.edu|
|Contact: David E Gerber, M.D. 214-648-4180 David.Gerber@UTSouthwestern.edu|
|Principal Investigator:||Lorraine Pelosof, M.D.||UT Southwestern Medical Center|