Clinical trial NCT02735356: Topical Itraconazole in Treating Patients With Basal Cell Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Skin Basal Cell Carcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-04-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage change of GLi levels in treated vs untreated tumors
timeFrame: Up to 1 month
Secondary outcomes:
measure: Change in BCC tumor size
timeFrame: At baseline, 1, 4, and 12 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
Study officials:
affiliation: Stanford Cancer Institute
name: Anthony Oro
role: PRINCIPAL_INVESTIGATOR
References: