Conditions: Basal Cell Carcinoma (BCC) Skin Cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 29
Healthy volunteers: no

Brief summary:
Basal cell carcinomas (BCCs) are the most common human cancer in the US and affect over 1 million people. There is no effective drug to prevent basal cell carcinomas of the skin.

We hope to learn if an oral anti-fungal drug, itraconazole, might inhibit a marker of proliferation and a biomarker (tumor signaling pathway) of BCC development.

Itraconazole is an FDA-approved drug for the treatment of fungal infections of the skin, and has been used for the past 25 years with relatively few side effects. It has been shown in mice to reduce a BCC biomarker and to reduce growth of BCCs.

Thus, it may reduce BCC growth in humans.

Detailed description:
Participants with at least one BCC tumor measuring 4 mm or greater in diameter will be enrolled onto 1 of 2 treatment cohorts to receive oral itraconazole.

* Cohort A - 400 mg itraconazole (as 200 mg twice daily for 30 days), stratified by:

  * Cohort A1 - Participants are vismodegib-naive.
  * Cohort A2 - Participants had received prior vismodegib treatment.
* Cohort B - 200 mg itraconazole (as 100 mg twice daily, for up to 4 months). The objective of this cohort is to assess the anti-cancer efficacy of lower-dose extended treatment.
* Control Group - Tumors from untreated participants.

Arms:
arm 1: Oral itraconazole 400 mg as 200 mg twice daily, for 1 month, stratified by prior vismodegib history arm 2: Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months arm 3: Patients otherwise eligible but unwilling to take itraconazole were enrolled onto the control arm of the study and received no treatment

Interventions: intervention 1: Itraconazole
Intervention descriptions: intervention 1: * Cohort A: oral itraconazole 400 mg as 200 mg twice daily; for 1 month
* Cohort B: oral itraconazole 200 mg as 100 mg twice daily; for up to 3 months

Protocol document: