Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas
This study has suspended participant recruitment.
Sponsor:
Stanford University
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
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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 May 16, 2013