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


Phase 2
18 Years
N/A
Not Enrolling
Both
Skin Cancers, Carcinoma, Basal Cell, Skin Cancer, Basal Cell Carcinoma

Thank you

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
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

Type of Study:

Interventional

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:

No

Principal Investigator

Jean Yuh Tang

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

SKIN0004

NCT ID:

NCT01108094

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

Name

Location

Stanford University School of Medicine Stanford, California  94305-5317