Trial Search Results

Arsenic Trioxide and Itraconazole in Treating Patients With Advanced Basal Cell Cancer

This pilot clinical trial studies how well arsenic trioxide and itraconazole work in treating patients with basal cell cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Itraconazole may help treat fungal infections in patients with basal cell cancer. Giving arsenic trioxide with itraconazole may work better in treating basal cell cancer.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Jean Yuh Tang

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Arsenic Trioxide
  • Drug: Itraconazole
  • Other: Laboratory Biomarker Analysis

Phase:

Early Phase 1

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Irene Bailey-Healy
408-892-7261
Not Recruiting