Oral Arsenic Trioxide and Itraconazole for the Treatment of Patients With Advanced Basal Cell Carcinoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change in Gli levels
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Arsenic Trioxide (Drug)
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.
干预措施: Itraconazole (Drug)
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.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Change in Gli levels
时间窗: Baseline to up to 1 month
Nonparametric methods (Wilcoxon sign rank test) will be used given then the continuous outcome and small sample size.
次要结局
- Tumor response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria(At 3 months)
研究者
Jean Yuh Tang
Associate Professor of Dermatology
Stanford University