| Eligibility |
Inclusion Criteria:
- Basal cell carcinoma (BCC)
- Patients ineligible for curative locoregional treatment and have either progressed on,
did not tolerate, unwilling to try or ineligible for investigational smoothened
antagonist such as Erivedge or Odomzo
- Life expectancy estimate > 3 months
- Performance status Eastern Cooperative Oncology Group (ECOG) 0 to 2
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) =<
2.5 X institutional upper limit of normal
- Creatinine =< 1.9 mg/dL
- Corrected QT (QTC) by 12 lead electrocardiography (EKG) < 450 msecs
- Serum potassium, magnesium and calcium levels which fall within normal limits or
levels outside the normal range determined not to be clinically significant by the
principal investigator (PI)
- Serum prothrombin time, international normalized ratio (INR) and partial
thromboplastin times which fall within normal limits or levels outside the normal
range determined not to be clinically significant by the PI
- Ability to understand and the willingness to sign a written informed consent document
- Females and males of reproductive potential must use effective contraception during
and after treatment for 6 months
Exclusion Criteria:
- Concurrent use of other investigational agents
- Cardiac arrhythmias
- Receiving potassium wasting diuretics or amphotericin must be noted to have
theoretically increased arrhythmia risks with arsenic trioxide (potassium wasting
diuretics or amphotericin are not excluded)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, liver disease, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, recurrent seizure history or psychiatric illness/social
situations that would limit compliance with treatment requirements
- Currently taking systemic medications that would affect BCC tumors (oral retinoids) or
metabolism of itraconazole (anti convulsants and corticosteroids); itraconazole should
not be taken with cisapride (Propulsid), dofetilide (Tikosyn), oral midazolam
(Versed), nisoldipine (Sular), pimozide (Orap), quinidine (Quinaglute), triazolam
(Halcion), or levomethadyl (Orlaam), lovastatin (Mevacor), simvastatin (Zocor), or an
ergot medication such as dihydroergotamine (Migranal), ergometrine or ergonovine
(Ergotrate Maleate), ergotamine (Ergomar), or methylergometrine or methylergonovine
(Methergine)
- History or current evidence of malabsorption or liver disease that would impair the
absorption of itraconazole
- History or current evidence of hyperthyroidism that would increase metabolism of
itraconazole
- Immunosuppressed patients (cancer, autoimmune disease) or patients taking
immunosuppressive drugs
- Pregnant or breastfeeding
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