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

Phase 2
18 Years
Not Enrolling
Skin Cancers, Carcinoma, Basal Cell, Skin Cancer, Basal Cell Carcinoma

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Trial Information

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

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

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

- Current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive

- Pregnant or lactating female

- Any female that is trying to get pregnant

Type of Study:


Study Design:

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

Outcome Measure:

oral or topical Itraconazole reduction of Basal Cell Carcinomas biomarkers

Outcome Time Frame:

3 weeks

Safety Issue:


Principal Investigator

Jean Yuh Tang

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

April 2010

Completion Date:

July 2012

Related Keywords:

  • Skin Cancers
  • Carcinoma, Basal Cell
  • Skin Cancer
  • Basal Cell Carcinoma
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Basal Cell



Stanford University School of Medicine Stanford, California  94305-5317