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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01108094
First Posted: April 21, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jean Yuh Tang, Stanford University
  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 may 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: Intervention Model: Single Group Assignment
Masking: None (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 Jean Yuh Tang, Stanford University:

Primary Outcome Measures:
  • oral or topical Itraconazole reduction of Basal Cell Carcinomas biomarkers [ Time Frame: 3 weeks ]

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) ]

Enrollment: 15
Study Start Date: April 2010
Study Completion Date: February 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Itraconazole 200 mg twice daily
200 mg twice daily; oral
Drug: Itraconazole
200 mg twice daily; oral
Other Name: Sporanox

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • At least one BCC tumor (greater than 4mm in diameter) at any skin location, 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 itraconazole during the 2 to 3 weeks between biopsy and surgical removal of BCC
  • Consent to research use of their BCC tissue.

Exclusion

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108094


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean Yuh Tang, Associate Professor of Dermatology, Stanford University
ClinicalTrials.gov Identifier: NCT01108094     History of Changes
Other Study ID Numbers: SKIN0004-TX
SU-04162010-5722 ( Other Identifier: Stanford University )
17365 ( Other Identifier: Stanford IRB )
First Submitted: April 19, 2010
First Posted: April 21, 2010
Last Update Posted: October 12, 2017
Last Verified: June 2016

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors