Evaluation Of The Treatment With Oral Itraconazole In Patients With Basocellular Carcinoma Of Skin, Locally Limited Disease.
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- clinical response
研究概览
简要总结
Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg twice daily, for 60 days, prior to curative intent surgery.
详细描述
Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg once daily, for 60 days, before surgery with curative intent.
Tumor area regression will be measured through dermatologic evaluation and photographic documentation on baseline and at the end of the 60 day treatment period.
The activity of the Hedgehog pathway will be measured on tissue samples obtained at the time of diagnosis and at the time of curative intent surgery, through the measuring of the Ki67 index.
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
- •Patients with diagnosis of Basocellular Carcinoma (BCC) of the Skin, histologically confirmed.
- •At least one BCC lesion with 10 mm in the longest diameter
- •Disease amenable to surgical intervention with curable intent.
- •Signed Informed Consent
- •PS ECOG 0 to 3
排除标准
- •Chronic renal disease, with a glomerular filtration rate of less than 30 ml/min
- •Acute or chronic liver disease, as measured by: total bilirubin > than 1.5 x ULN and AST and ALT > than 5 x ULN.
- •Symptomatic cardiac insufficiency or an ejection fraction lower than 50% measured through echocardiography,
- •Other active malignancies in the last year.
- •Uncontrolled systemic hypertension,
- •Any chronic infections such as tuberculosis, viral hepatitis and HIV.
- •Pregnancy, suspected or confirmed.
- •Known intolerance to the use of Itraconazole.
研究组 & 干预措施
Itraconazole
Oral Itraconazole capsules, 200 mg
干预措施: Itraconazole 200 mg (Drug)
结局指标
主要结局
clinical response
时间窗: 60 days
tumor area response registered through dermatologic evaluation
hedgehog pathway activity
时间窗: 60 days
Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.
次要结局
未报告次要终点