Topical Itraconazole in Treating Patients With Basal Cell Cancer

Jean Yuh Tang

Status and phase

Completed

Early Phase 1

Conditions

Skin Basal Cell Carcinoma

Treatments

Drug: Itraconazole

Other: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02735356

P30CA124435 (U.S. NIH Grant/Contract)

NCI-2016-00452 (Registry Identifier)

SKIN0030 (Other Identifier)

IRB-35672

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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