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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jean Yuh Tang, Stanford University
ClinicalTrials.gov Identifier:
NCT01108094
First received: April 19, 2010
Last updated: January 11, 2016
Last verified: January 2016
  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: 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: December 2016
Estimated Primary Completion Date: December 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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  17365 
Study First Received: April 19, 2010
Last Updated: January 11, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Data and Safety Monitoring Board

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

ClinicalTrials.gov processed this record on May 05, 2016