Back to resultsArsenic Trioxide and Itraconazole in Treating Patients With Advanced Basal Cell Cancer
Primary Purpose
Skin Basal Cell Carcinoma
Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Arsenic Trioxide
Itraconazole
Laboratory Biomarker Analysis
Sponsored by
About this trial
This is an interventional treatment trial for Skin Basal Cell Carcinoma
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (arsenic trioxide, itraconazole)
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Gli levels
Nonparametric methods (Wilcoxon sign rank test) will be used given then the continuous outcome and small sample size.
Secondary Outcome Measures
Tumor response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Proportion of subjects with complete response, partial response, stable disease, or disease progression by RECIST criteria.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02699723
Brief Title
Arsenic Trioxide and Itraconazole in Treating Patients With Advanced Basal Cell Cancer
Official Title
Oral Arsenic Trioxide and Itraconazole for the Treatment of Patients With Advanced Basal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Logistics
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jean Yuh Tang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Basal Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (arsenic trioxide, itraconazole)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Arsenic Trioxide
Other Intervention Name(s)
Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid, Arsenous Acid Anhydride, Arsenous Oxide, Trisenox, White Arsenic
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Itraconazole
Other Intervention Name(s)
Lozanoc, Oriconazole, R 51,211, Sporanox
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Change in Gli levels
Description
Nonparametric methods (Wilcoxon sign rank test) will be used given then the continuous outcome and small sample size.
Time Frame
Baseline to up to 1 month
Secondary Outcome Measure Information:
Title
Tumor response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Description
Proportion of subjects with complete response, partial response, stable disease, or disease progression by RECIST criteria.
Time Frame
At 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Tang
Organizational Affiliation
Stanford Cancer Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Arsenic Trioxide and Itraconazole in Treating Patients With Advanced Basal Cell Cancer
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