NCT00087386终止2 期
Phase II Trial of 17-N-allylamino-17-demethoxy Geldanamycin (17-AAG, NSC #330507) Diluted in EPL Diluent (NSC #704057) in Metastatic Melanoma Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Response rate (complete and partial response)
研究概览
简要总结
This phase II trial is studying how well tanespimycin works in treating patients with stage III or stage IV melanoma. Antitumor antibiotics such as tanespimycin may stop the growth of melanoma by stopping blood flow to the tumor.
详细描述
PRIMARY OBJECTIVES:
I. Determine if treatment with 17-AAG results in measurable anti-tumor effects and calculate the proportion of clinical responses.
II. Test the hypothesis that treatment with 17-AAG can disrupt the MAPK pathway by depleting intra-tumor stores of RAF kinases and/or downstream proteins such as phospho-ERK, CDK4 and cyclin D1.
III. Determine if either of these effects correlates with the presence of mutated BRAF within the melanoma tumor.
OUTLINE: This is a multicenter study. Patients are stratified according to presence of BRAF mutation in tumor (yes vs no).
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 melanoma
- •Stage III or IV disease
- •No primary melanoma of the choroid or mucosa
- •Measurable disease
- •At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- •Tumor amenable to biopsy (for the first 10 patients in each stratum only)
- •Patients must have measurable disease in addition to the tumor(s) to be biopsied
- •No brain or epidural metastases
- •Completely resected solitary brain metastases allowed provided patient has been free of CNS metastases for >= 6 months
- •Performance status - Karnofsky 60-100%
- •Performance status - ECOG 0-2
- •More than 3 months
- •Absolute neutrophil count >= 1,500/mm^3
- •Platelet count >= 100,000/mm^3
- •WBC >= 3,000/mm^3
- •AST and ALT =< 2.5 times upper limit of normal
- •Creatinine normal
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No history of myocardial infarction
- •No history of prolonged QTc interval
- •No active ischemic heart disease within the past 12 months
- •No uncontrolled dysrhythmia or dysrhythmias requiring medication
- •No congenital prolonged QT syndrome
- •No left bundle branch block
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior allergic reaction attributed to compounds of similar chemical or biological composition to 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)
- •No prior serious allergic reaction to eggs
- •No other uncontrolled illness
- •No active or ongoing infection requiring systemic antimicrobial treatment
- •No psychiatric illness or social situation that would preclude study compliance
- •No more than 1 prior chemotherapy regimen for metastatic melanoma
- •Prior vaccines, cytokines, or interferon alfa is not considered prior therapy unless administered with a chemotherapy drug
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •Prior radiotherapy dose =< 3,000 cGy to fields including substantial marrow
- •More than 4 weeks since prior radiotherapy and recovered
- •No prior radiotherapy field that included the heart (e.g., mantle)
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No concurrent medications that may prolong the QTc interval
- •No other concurrent anticancer therapy
- •No other concurrent investigational agents
- •No concurrent treatment with any of the following medications or herbal remedies:
- •Inhibitors of CYP3A4:
- •Fluconazole
- •Itraconazole
- •Ketoconazole
- •Macrolide antibiotics (azithromycin, clarithromycin, erythromycin, or troleandomycin)
- 另有 22 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (tanespimycin)
Experimental
Patients receive tanespimycin IV over 1-6 hours once weekly for 6 weeks. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
干预措施: tanespimycin (Drug)
Treatment (tanespimycin)
Experimental
Patients receive tanespimycin IV over 1-6 hours once weekly for 6 weeks. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Response rate (complete and partial response)
时间窗: Up to 3 years
次要结局
- Proportion of patients with stable disease(At 1 year)
- Frequency of toxicities(Up to 3 years)
研究者
研究点 (1)
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