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

NCT02699723 | Withdrawn Early Phase 1 DMC FDA Drug

• 3 other identifiers: IRB-35488NCI-2016-00180SKIN0033
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Skin Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Change in Gli levels

  Nonparametric methods (Wilcoxon sign rank test) will be used given then the continuous outcome and small sample size.

  Baseline to up to 1 month

Secondary Outcomes (1)

• Tumor response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria

  At 3 months

Study Arms (1)

Treatment (arsenic trioxide, itraconazole)

EXPERIMENTAL

Patients receive arsenic trioxide 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.

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

Interventions

Arsenic Trioxide DRUG

Given PO

Also known as: Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid, Arsenous Acid Anhydride, Arsenous Oxide, Trisenox, White Arsenic

Treatment (arsenic trioxide, itraconazole)

Itraconazole DRUG

Given PO

Also known as: Lozanoc, Oriconazole, R 51,211, Sporanox

Treatment (arsenic trioxide, itraconazole)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (arsenic trioxide, itraconazole)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jean Yuh Tang: lead

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Arsenic Trioxide; arsenous acid; Itraconazole

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Jean Tang

  Stanford Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 4, 2016
• Study Start: December 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share