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

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Skin Cancers; Carcinoma, Basal Cell; Skin Cancer; Basal Cell Carcinoma

Intervention: Itraconazole (Drug)

Phase: Phase 2

Status: Suspended

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Jean Yuh Tang, Principal Investigator, Affiliation: Stanford University

Summary

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.

Clinical Details

Official title: Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients With Basal Cell Carcinomas

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: oral or topical Itraconazole reduction of Basal Cell Carcinomas biomarkers

Secondary outcome: Topical Itraconazole penetration Basal Cell Carcinomas tumors.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information

Starting date: April 2010
Last updated: July 11, 2012

Page last updated: August 23, 2015

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