Topical Itraconazole in Treating Patients With Basal Cell Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Basal Cell Carcinoma
• Intervention / Treatment: Other: Placebo; Drug: Itraconazole

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment (itraconazole and placebo); Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.	Other: Placebo; Applied topically; Other Names: placebo therapy; PLCB; sham therapy; Drug: Itraconazole; Applied topically; Other Names: Sporanox; Lozanoc; Oriconazole; R 51,211

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change of GLi levels in treated vs untreated tumors	will be assessed as relative GLi1 mRNA expression	Up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jean Yuh Tang
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Anthony Oro, Stanford Cancer Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2016
• Primary Completion (ACTUAL): September 19, 2017
• Study Completion (ACTUAL): October 10, 2017

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (ESTIMATE): April 12, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole
• Other Study ID Numbers: IRB-35672; P30CA124435 (U.S. NIH Grant/Contract); NCI-2016-00452 (REGISTRY: CTRP (Clinical Trial Reporting Program)); SKIN0030 (OTHER: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No