Topical Itraconazole in Treating Patients With Basal Cell Cancer

Skin Basal Cell Carcinoma Clinical Trial

Official title:

A Case Study of the Effects of Topical Itraconazole on Pharmacodynamic Modulation of Hedgehog Target Gene Expression in Basal Cell Carcinomas in Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02735356
• Other study ID #: IRB-35672
• Secondary ID: NCI-2016-00452SK
• Status: Completed
• Phase: Early Phase 1
• Start date: May 5, 2016
• Est. completion date: October 10, 2017

Study information

• Verified date: April 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase 0 trial studies how well itraconazole gel works in treating patients with basal cell cancer. Itraconazole gel may help to treat basal cell tumors in patients.

Description:

PRIMARY OBJECTIVES:

I. To determine if 12 weeks of topical itraconazole gel reduces basal cell carcinoma (BCC) biomarkers (Gli1, the target gene of the Hedgehog pathway).

SECONDARY OBJECTIVES:

I. To determine if topical itraconazole gel will decrease BCC size.

OUTLINE:

Patients apply itraconazole topically twice daily (BID) and placebo topically BID for 12 weeks.

After completion of study treatment, patients are followed up for up to 14 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 10, 2017
• Est. primary completion date: September 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject must sign and date all informed consent statements; children will sign the assent form and their guardian will sign the consent form

• The subject must be willing to apply the medications twice daily for 1 month

• The subjects must have at least four BCCs in non-cosmetically sensitive sites

• For women of child-bearing potential, a negative urine pregnancy test

• Women of child-bearing potential are expected to use an effective method of birth control to prevent exposing a fetus to potentially dangerous agent with unknown risk

• For male patients with female partners of childbearing potential, agreement to use adequate contraception while you are participating in the study and 1 month after applying your last dose

Exclusion Criteria:

• Pregnancy or breast-feeding

• History of congestive heart failure or other findings of ventricular dysfunction

• History of current evidence of malabsorption or liver disease

• Current immunosuppression or taking immunosuppressive drugs

• Taking oral itraconazole

• Taking any medication known to affect hedgehog (HH) signaling pathway

• The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study; specifically these include the topical use to the study tumors of: glucocorticoids (ii) retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically (iii) alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to more than 5% of the skin during the six months prior to study entry (iv) 5-fluorouracil or imiquimod; also - treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling within 60 days to starting study medication

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Skin Basal Cell Carcinoma

Intervention

Drug:
• Itraconazole
Applied topically

Other:
• Placebo
Applied topically

Locations

Country	Name	City	State
United States	Stanford Cancer Institute	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Jean Yuh Tang	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change of GLi levels in treated vs untreated tumors	will be assessed as relative GLi1 mRNA expression	Up to 1 month
Secondary	Change in BCC tumor size	Analyzed based on tumor size change (longest diameter, Response Evaluation Criteria in Solid Tumors [RECIST] criteria).	At baseline, 1, 4, and 12 weeks