Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: Itraconazole

Phase:

Phase 2

Eligibility


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

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
ccto-office@stanford.edu
650-498-7061
Not Recruiting