NCT00079131已完成2 期
A Phase II Study of G3139 (Genasense ™) in Patients With Merkel Cell Carcinoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
This phase II trial is studying how well oblimersen works in treating patients with Merkel cell cancer. Biological therapies, such as oblimersen, may interfere with the growth of tumor cells and slow the growth of Merkel cell carcinoma (skin cancer).
详细描述
PRIMARY OBJECTIVES:
I. Determine the overall response rate in patients with Merkel cell carcinoma treated with oblimersen.
SECONDARY OBJECTIVES:
I. Determine the time to progression in patients treated with this drug. II. Determine the response duration in patients treated with this drug. III. Determine the safety and tolerability of this drug in these patients. IV. Determine the pharmacodynamic effects of this drug on bcl-2 expression and apoptosis in tumor biopsy specimens from these patients.
OUTLINE: This is an open-label, multicenter study.
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
- •Histologically or cytologically confirmed Merkel cell carcinoma
- •Metastatic OR regionally recurrent disease
- •Localized disease not amenable to curative therapy (surgery or radiotherapy) also allowed
- •Measurable disease
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •No known brain metastases
- •Previously resected or irradiated brain metastases allowed if stable for at least the past 3 months and no evidence of neurological compromise exists
- •Performance status - Karnofsky 60-100%
- •Absolute neutrophil count >= 1,500/mm^3
- •Platelet count >= 100,000/mm^3
- •WBC >= 3,000/mm^3
- •AST/ALT =< 2.5 times upper limit of normal
- •Bilirubin normal
- •INR =< 1.5
- •Creatinine normal
- •Creatinine clearance >= 60 mL/min
- •No atrial fibrillation unless stable for at least the past 6 months
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Adequate venous access
- •No peripheral neuropathy > grade 1
- •No active or ongoing infection
- •No other concurrent uncontrolled illness
- •No prior grade 3 or 4 anaphylactic reaction to phosphorothioate oligonucleotide
- •No psychiatric illness or social situation that would preclude study compliance
- •More than 3 weeks since prior chemotherapy and recovered
- •More than 3 weeks since prior radiotherapy and recovered
- •No prior radiotherapy to 25% or more of bone marrow
- •More than 3 weeks since prior investigational therapy and recovered
- •No prior oblimersen
- •No other concurrent investigational agents
- •No concurrent anticoagulation except 1 mg of warfarin for mediport patency
- •No concurrent combination antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
结局指标
主要结局
Overall response rate
时间窗: Up to 3 years
次要结局
- Time to progression(Interval between the start of treatment and until the criteria for progression are met, assessed up to 3 years)
- Occurrence of adverse events, assessed using revised NCI CTC version 3.0(Within 30 days of treatment)
研究者
研究点 (1)
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