Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas

This study is currently recruiting participants.

Verified December 2011 by Stanford University

First Received on April 19, 2010. Last Updated on December 8, 2011 History of Changes

Sponsor:	Stanford University
Information provided by (Responsible Party):	Stanford University
ClinicalTrials.gov Identifier:	NCT01108094

Purpose

BCCs are the most common human cancer in the US and affect over 1 million people. There is no effective drug to prevent basal cell carcinomas of the skin. We hope to learn if an oral antifungal drug, Itraconazole, might inhibit a marker of proliferation and a biomarker (tumor signaling pathway) of BCC development. Itraconazole is an FDA-approved drug for the treatment of fungal infections of the skin, and has been used for the past 25 years with relatively few side effects. It has been shown in mice to reduce a BCC biomarker and to reduce growth of BCCs. Thus, it could potentially reduce BCC growth in humans.

Condition	Intervention	Phase
Skin Cancers Carcinoma, Basal Cell Skin Cancer Basal Cell Carcinoma	Drug: Itraconazole	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients With Basal Cell Carcinomas

Resource links provided by NLM:

MedlinePlus related topics: Cancer Skin Cancer

Drug Information available for: Itraconazole

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

oral or topical Itraconazole reduction of Basal Cell Carcinomas biomarkers [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Topical Itraconazole penetration Basal Cell Carcinomas tumors. [ Time Frame: after 2-3 weeks of topical (400mg daily) vs. oral Itraconazole (400 mg daily) ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	April 2010
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Intervention Details:

200 mg twice daily; oral

Other Name: Sporanox

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:- Have at least one BCC tumor (greater than 4mm in diameter) at any skin location, which needs to be biopsied and surgically removed.

Had at least one liver function test (AST, ALT) with normal results in the last year.
Willing to take drug during the 2-3 weeks between biopsy and surgical removal of BCC.
Consent to research use of their BCC tissue.

Exclusion Criteria:- No history or current hepatitis or other liver disease.

Currently taking systemic medications that would affect BCC tumors (oral retinoids) or metabolism of Itraconazole (anti-convulsants, corticosteroids)
History or current evidence of malabsorption or liver disease that would impair the absorption of Itraconazole as measured by liver function tests within the past one year prior to enrollment.
History or current evidence of hyperthyroidism that would increase metabolism of Itraconazole.
Unable to attend to 2nd study visit at Stanford for MOHS surgical excision
Current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs.
Pregnant or lactating female
Any female that is trying to get pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108094

Contacts

Contact: Jean Tang

(650) 721-7152

tangy@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Jean Tang 650-721-7152 tangy@stanford.edu
Contact: Cancer Clinical Trials Office (650) 498-7061
Principal Investigator: Jean Yuh Tang
Sub-Investigator: Eleni Linos

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Jean Yuh Tang

Stanford University

More Information

No publications provided

Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT01108094 History of Changes
Other Study ID Numbers:	SKIN0004, SU-04162010-5722
Study First Received:	April 19, 2010
Last Updated:	December 8, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Carcinoma
Skin Neoplasms
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Skin Diseases
Neoplasms, Basal Cell

Itraconazole
Hydroxyitraconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012