NCT00295984已完成2 期
Treatment of Classical Kaposi Sarcoma With Nicotine Dermal Patch: A Phase II Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Tumor response at weeks 9 and 15
研究概览
简要总结
RATIONALE: Nicotine may stimulate the immune system to kill Kaposi's sarcoma cells.
PURPOSE: This phase II trial is studying the side effects and how well the nicotine skin patch works in treating patients with Kaposi's sarcoma.
详细描述
OBJECTIVES:
- Evaluate the toxicity and efficacy of transdermal nicotine applied to lesions in patients with classic Kaposi's Sarcoma.
OUTLINE: This is a double-blind, placebo-controlled study.
Patients apply a nicotine dermal patch to a selected lesion and a placebo patch to the other lesion, replacing the same type of fresh patch every other day, during the first 2 weeks, increasing the nicotine dose in week 3 and again in week 5 for a total of 15 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven classic Kaposi's sarcoma (KS)
- •At least 2 KS lesions that can be measured (minimum diameter 0.5 cm to maximum diameter 3 cm) and located on body sites (leg, arm, torso, dorsum of foot or hand) to which a patch can be applied
- •A third measurable lesion (if available) of the same size can be located on any body site
- •KS lesions must be separated by at least 8.0 cm at their centers and 6.0 cm at closest edges
- •Patient must be a nonsmoker
- •No smoking, chewing, or other use of tobacco within the past year
- •PATIENT CHARACTERISTICS:
- •HIV antibody negative
- •Willing to shower or bathe no more than every other day
- •No life-threatening conditions
- •Not pregnant
- •Fertile patients must use effective contraception
- •Chronic conditions (e.g., hypertension or diabetes) must be stable and well controlled
- •No history of HIV/AIDS, unstable angina pectoris, or claudication
- •ECOG performance status 0-1
- •PRIOR CONCURRENT THERAPY:
- •No prior biopsy of the selected KS lesion(s) within the past 90 days
- •No prior systemic therapy for KS within the past 90 days
- •No concurrent systemic or local conventional treatment for KS
- •No prior use of a nicotine product within the past year
- •No prior surgery, chemotherapy, biologic therapy, or radiotherapy within the past 90 days
- •No prior organ allograft
排除标准
- 未提供
结局指标
主要结局
Tumor response at weeks 9 and 15
次要结局
未报告次要终点
研究者
研究点 (2)
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