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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01108094
First received: April 19, 2010
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Skin Cancers
Carcinoma, Basal Cell
Skin Cancer
Basal Cell Carcinoma
Drug: Itraconazole
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients With Basal Cell Carcinomas

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • oral or topical Itraconazole reduction of Basal Cell Carcinomas biomarkers [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Topical Itraconazole penetration Basal Cell Carcinomas tumors. [ Time Frame: after 2-3 weeks of topical (400mg daily) vs. oral Itraconazole (400 mg daily) ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Itraconazole
    200 mg twice daily; oral
    Other Name: Sporanox
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108094

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jean Yuh Tang Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01108094     History of Changes
Other Study ID Numbers: SKIN0004, SU-04162010-5722
Study First Received: April 19, 2010
Last Updated: July 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Skin Neoplasms
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Skin Diseases
Neoplasms, Basal Cell
Itraconazole
Hydroxyitraconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014