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Arsenic Trioxide and Itraconazole in Treating Patients With Advanced Basal Cell Cancer | Clinical Trials | Clareo Health

WITHDRAWNEARLY_PHASE1

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

Oral Arsenic Trioxide and Itraconazole for the Treatment of Patients With Advanced Basal Cell Carcinoma

NCT02699723•Jean Yuh Tang

View on ClinicalTrials.gov

Summary

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.

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate the response of arsenic trioxide/itraconazole in patients with refractory basal cell carcinoma. SECONDARY OBJECTIVES: I. To determine if this treatment is associated with a reduction in Gli messenger ribonucleic acid (mRNA) levels in tumor and/or normal skin biopsy samples, when compared to baseline levels. OUTLINE: Patients receive arsenic trioxide orally (PO) and itraconazole PO daily for 50 days, followed by maintenance therapy consisting of 2 weeks off treatment and then 2 weeks on treatment for up to 6 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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

Key Dates

Start Date

December 1, 2020

Primary Completion Date

September 1, 2021

Completion Date

September 1, 2021

Last Updated

October 22, 2020

Conditions

Skin Basal Cell Carcinoma

Interventions

Arsenic Trioxide

DRUG

Itraconazole

DRUG

Laboratory Biomarker Analysis

OTHER

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TERMINATEDPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 22, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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