Topical Itraconazole in Treating Patients With Basal Cell Cancer

• Status: Completed
• Trial end date: 2017-10-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jean Yuh Tang
• Collaborator: National Cancer Institute (NCI)
• Treatments: Hydroxyitraconazole; Itraconazole

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