Topical Itraconazole in Treating Patients With Basal Cell Cancer

Early Phase 1

Completed

• Conditions: Skin Basal Cell Carcinoma
• Interventions: Drug: Itraconazole; Other: Placebo

• Registration Number: NCT02735356
• Lead Sponsor: Jean Yuh Tang

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-12
• Study Start: 2016-05-05
• Primary Completion: 2017-09-19
• Study Completion: 2017-10-10
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (itraconazole and placebo)	Placebo	Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.
Treatment (itraconazole and placebo)	Itraconazole	Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage change of GLi levels in treated vs untreated tumors	Up to 1 month	will be assessed as relative GLi1 mRNA expression

Secondary Outcome Measures

Name	Time	Method
Change in BCC tumor size	At baseline, 1, 4, and 12 weeks	Analyzed based on tumor size change (longest diameter, Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria).

Trial Locations

Locations (1)

Stanford Cancer Institute; 🇺🇸 Palo Alto, California, United States