NCT00132015已完成2 期
A Phase II Clinical Trial of 17-(Allylamino)-17- Demethoxygeldanamycin (17-AAG, NSC 330507 and EPL Diluent, NSC 704057) in Adults With Systemic Mastocytosis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Objective response (complete and partial response)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well 17-AAG works in treating patients with systemic mastocytosis.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), in terms of decreases in the number of mast cells in the bone marrow and in serum tryptase levels, in patients with systemic mastocytosis.
Secondary
- Determine the quality of life of patients treated with this drug.
- Determine hematological and non-hematological toxicity of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed systemic mastocytosis
- •Objective evidence of disease, as defined by the following:
- •Hemoglobin < 10 g/dL
- •Recurrent mast cell mediator-release symptoms that impair the patient's quality of life
- •Symptomatic hepatosplenomegaly
- •Symptomatic bone disease
- •Profound constitutional symptoms (e.g., fatigue, asthenia, flushing, hyperpyrexia, weight loss, myalgia, and arthralgia)
- •Elevated serum tryptase level
- •Mast cell leukemia allowed
- •Mastocytosis associated with myeloproliferative disease (e.g., hypereosinophilic syndrome or chronic myelomonocytic leukemia) allowed
- •Patients with eosinophilia (i.e., absolute eosinophil count ≥ 1,000/mm^3) must be evaluated for the presence or absence of FIP1L1-PDGFRA mutation; if the mutation is absent, the patient is eligible; if the mutation is present, the patient is eligible provided disease is refractory to imatinib mesylate
- •Patients with indolent disease must have a serum tryptase level ≥ 50 ng/mL OR episodes of anaphylaxis that occur with a frequency of > 1 per month
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •See Disease Characteristics
- •Platelet count ≥ 100,000/mm^3 (> 25,000/mm^3 for patients with organomegaly)
- •Absolute granulocyte count ≥ 1,500/mm^3(> 750/mm^3 for patients with organomegaly)
- •AST and ALT ≤ 2 times upper limit of normal (ULN) (< 4 times ULN for patients with hepatomegaly)
- •Bilirubin normal
- •Alkaline phosphatase ≤ 3 times ULN
- •Creatinine ≤ 1.4 mg/dL OR
- •Creatinine clearance ≥ 60 mL/min
- •Cardiovascular
- •No New York Heart Association class III-IV congestive heart failure
- •No history of myocardial infarction within the past year
- •No history of uncontrolled dysrhythmia
- •No uncontrolled angina
- •No ischemic heart disease within the past 12 months
- •No congenital long QT syndrome
- •No left bundle branch block
- •No serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- •QTc interval < 450 msec for males or 470 msec for females
- •LVEF > 40% by MUGA
- •MUGA or echocardiogram normal
- •No prior history of cardiac toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine)
- •No cardiac symptoms ≥ grade 2
- •No other significant cardiac disease
- •No symptomatic pulmonary disease requiring medication including any of the following:
- •Dyspnea on or off exertion
- •Paroxysmal nocturnal dyspnea
- •Requirement for oxygen
- •Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary disease)
- •No home oxygen meeting the Medicare requirement
- •No compromised pulmonary status (i.e., DLCO ≤ 80%)
- •No prior history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine)
- 另有 30 项未显示
排除标准
- 未提供
结局指标
主要结局
Objective response (complete and partial response)
次要结局
- Quality of life as assessed by the European Organization for Research of the Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at baseline and prior to each treatment course
研究者
研究点 (4)
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