NCT00079300已完成1 期
Double-Blind, Vehicle-Controlled Study to Evaluate Apoptosis in Basal Cell Carcinoma Treated With Aldara™ (Imiquimod) Cream, 5% Applied Once or Twice a Day
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Biological therapies, such as imiquimod cream, work in different ways to stimulate the immune system and stop tumor cells from growing.
PURPOSE: This randomized phase I trial is studying how well imiquimod cream works in treating patients with basal cell skin cancer.
详细描述
OBJECTIVES:
Primary
- Compare levels of apoptosis in patients with basal cell skin cancer treated with vs without imiquimod 5% cream.
Secondary
- Compare levels of apoptosis in patients treated with this drug on two different administration schedules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed basal cell skin cancer
- •Superficial or nodular disease
- •No aggressive disease
- •At least 1 lesion at least 7 mm in diameter that meets the following criteria:
- •Primary tumor (no recurrent or previously treated disease)
- •Located on the scalp, face (including ears), trunk, or proximal extremities
- •Qualifies for surgical excision as primary therapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular
- •No evidence of a clinically significant or unstable medical condition that would adversely affect blood circulation
- •No dermatological disease (e.g., psoriasis or eczema) at the treatment site that may be exacerbated by treatment with imiquimod or interfere with examination
- •No febrile viral infection within the past 4 weeks
- •No evidence of a clinically significant or unstable medical condition that would adversely affect immune function
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior interferon, interferon inducers, or immunomodulators
- •No concurrent interferon, interferon inducers, or immunomodulators
- •Chemotherapy
- •More than 6 months since prior anticancer chemotherapy
- •No concurrent anticancer chemotherapy
- •Endocrine therapy
- •More than 4 weeks since prior oral or inhaled (more than 600 mcg/day for fluticasone or equivalent) corticosteroids
- •More than 4 weeks since prior topical steroids to the target tumor
- •Concurrent topical steroids in non-target areas are allowed provided amount used is ≤ 2 g of fluorinated steroids daily for > 1 week or 6 g of beclomethasone for > 1 week
- •No concurrent oral or inhaled corticosteroids
- •Radiotherapy
- •Not specified
- •More than 4 months since prior biopsy
- •More than 4 weeks since prior immunosuppressive therapies
- •More than 4 weeks since prior cytotoxic or investigational drugs
- •No concurrent immunosuppressive therapies
- •No other concurrent cytotoxic or investigational drugs
排除标准
- 未提供
研究者
研究点 (2)
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