Fotemustine in Treating Patients With Metastatic Melanoma
Phase II Study of the Predictive Value of the Expression of Tumoral MGMT With Respect to the Therapeutic Response of Fotemustine in Patients With Metastatic Malignant Melanoma
RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.
PURPOSE: This phase II trial is studying fotemustine to see how well it works in treating patients with metastatic melanoma.
研究概览
详细说明
OBJECTIVES:
Primary
- Assess the relationship between MGMT expression and response to fotemustine in patients with metastatic malignant melanoma.
Secondary
- Establish a value for MGMT expression below which fotemustine has a strong probability of effectiveness.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising fotemustine IV over 1 hour on days 1, 8, and 15. Beginning 5 weeks later, patients achieving stable or objective response receive maintenance chemotherapy comprising fotemustine IV over 1 hour once every 3 weeks for 6 courses.
Tissue samples are collected at baseline to assess level of MGMT expression by PCR.
After completion of study treatment, patients are followed every 2 months.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Montpellier、法国、34298
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic malignant melanoma, meeting the following criteria:
- Metastatic lymph nodes or skin allowing for surgical resection
- At least 1 metastatic lesion (lymph nodes, skin, visceral, brain)
- Measurable or evaluable disease
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC > 2 x 10^9/L
- Platelet count > 100 x 10^9/L
- Transaminases ≤ 2.5 times normal
- Alkaline phosphate ≤ 2.5 times normal
- Total bilirubin normal
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No severe uncontrolled infection
- No other prior or concurrent malignancy (except basal cell or squamous cell carcinoma in situ of the cervix that was curatively treated)
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- At least 2 weeks since prior adjuvant therapy
- At least 4 weeks since prior radiotherapy
- At least 30 days since prior participation in another clinical trial
- No prior or concurrent prophylactic phenytoin
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
研究衡量的是什么？
主要结果指标
结果测量 |
|---|
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Relationship between MGMT expression and response to fotemustine
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次要结果测量
结果测量 |
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Value for MGMT expression below which fotemustine has a strong probability of effectiveness
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合作者和调查者
调查人员
- 学习椅：Didier Cupissol, MD, PhD、Institut du Cancer de Montpellier - Val d'Aurelle
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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