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

Sponsored by Stanford University

About this trial

Last updated 7 years ago

Study ID

IRB-17365

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 14 years ago

What is this trial about?

Basal cell carcinomas (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 anti-fungal 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 may reduce BCC growth in humans.

What are the participation requirements?

Yes

Inclusion Criteria

- At least one BCC tumor (greater than 4 mm in diameter) at any skin location, to be biopsied and surgically removed.

- Had at least one liver function test [eg, aspartate aminotransferase (AST), alanine aminotransferase (ALT)] with normal results in the last year.

- Consent to research use of their BCC tissue.

- Cohort A or B: Willing to take itraconazole during the 2 to 3 weeks between biopsy and surgical removal of BCC

No

Exclusion Criteria

- 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 within the one year prior to enrollment.

- History or current evidence of hyperthyroidism increasing metabolism of itraconazole

- Unable to attend to 2nd study visit at Stanford for Mohs surgical excision

- Current immunosuppression disease (cancer, autoimmune disease)

- Receiving immunosuppressive drugs

- Pregnant

- Lactating

- Any female actively trying to become pregnant

Locations

Location

Status