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

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ClinicalTrials.gov Identifier: NCT02699723
Recruitment Status : Not yet recruiting
First Posted : March 4, 2016
Last Update Posted : December 13, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jean Yuh Tang, Stanford University

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.

Condition or disease Intervention/treatment Phase
Skin Basal Cell Carcinoma Drug: Arsenic Trioxide Drug: Itraconazole Other: Laboratory Biomarker Analysis Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Arsenic Trioxide and Itraconazole for the Treatment of Patients With Advanced Basal Cell Carcinoma
Study Start Date : January 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arsenic

Arm Intervention/treatment
Experimental: Treatment (arsenic trioxide, itraconazole)
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
Given PO
Other Names:
  • Arsenic (III) Oxide
  • Arsenic Sesquioxide
  • Arsenous Acid
  • Arsenous Acid Anhydride
  • Arsenous Oxide
  • Trisenox
  • White Arsenic

Drug: Itraconazole
Given PO
Other Names:
  • Lozanoc
  • Oriconazole
  • R 51,211
  • Sporanox

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. Change in Gli levels [ Time Frame: Baseline to up to 1 month ]
    Nonparametric methods (Wilcoxon sign rank test) will be used given then the continuous outcome and small sample size.


Secondary Outcome Measures :
  1. Tumor response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: At 3 months ]
    Proportion of subjects with complete response, partial response, stable disease, or disease progression by RECIST criteria.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699723


Contacts
Contact: Irene Bailey-Healy 408-892-7261 baileyhi@stanford.edu

Locations
United States, California
Stanford Cancer Institute Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Irene Bailey-Healy    408-892-7261    baileyhi@stanford.edu   
Principal Investigator: Jean Tang         
Sponsors and Collaborators
Jean Yuh Tang
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jean Tang Stanford Cancer Institute

Responsible Party: Jean Yuh Tang, Associate Professor of Dermatology, Stanford University
ClinicalTrials.gov Identifier: NCT02699723     History of Changes
Other Study ID Numbers: SKIN0033
NCI-2016-00180 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SKIN0033 ( Other Identifier: Stanford Cancer Institute )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Itraconazole
Hydroxyitraconazole
Arsenic trioxide
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antineoplastic Agents