NCT00100997已完成1 期
A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Intravenously Administered CNF1010 )17-(Allylamino)-17-Demethoxygeldanamycin [17-AAG]) in Patients With Gleevec-Resistent Chronic Myelogenous Leukemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with chronic phase chronic myelogenous leukemia that did not respond to imatinib mesylate.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), in terms of frequency, severity, and duration of treatment-emergent adverse events, in patients with imatinib mesylate-resistant Philadelphia chromosome (Ph)-positive chronic phase chronic myelogenous leukemia.
- Determine the pharmacokinetics of this drug and its primary metabolite (17-amino-17-demethoxygeldanamycin) in these patients.
Secondary
- Determine the hematologic response rate, in terms of WBC count, platelet count, and assessment of blast cells in peripheral blood, in patients treated with this drug.
- Determine the cytogenic response rate, in terms of Ph-positive progenitor cells in the bone marrow, in patients treated with this drug.
- Assess the effect of this drug on pharmacodynamic markers (i.e., CRKL phosphorylation, BCR-ABL kinase activity, and BCR-ABL, RAF kinase, and HSP70 expression) 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:
- •Diagnosis of chronic phase chronic myelogenous leukemia
- •Philadelphia chromosome (Ph)-positive disease
- •Hematologic resistence after treatment with imatinib mesylate (400 mg per day or maximum tolerated dose [MTD]) as defined by 1 of the following criteria:
- •Loss of complete hematologic response, defined as WBC count OR platelet count > upper limit of normal (ULN) on 2 separate occasions at least 2 weeks apart that cannot be attributed to other etiologies
- •Absolute increase of ≥ 30% in Ph-positive cells while on a stable dose of imatinib mesylate for at least 6 months* NOTE: *Patients meeting this criterion are not eligible for enrollment into the expanded MTD cohort
- •Less than 15% blasts in peripheral blood or bone marrow AND < 30% blasts and promyelocytes in peripheral blood or bone marrow
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •See Disease Characteristics
- •Bilirubin < 1.5 times ULN (3 mg/dL for patients with Gilbert's syndrome)
- •ALT or AST < 2 times ULN
- •No known hepatitis positivity
- •Creatinine < 1.5 times ULN OR
- •Creatinine clearance > 60 mL/min
- •Cardiovascular
- •No New York Heart Association class III or IV cardiac disease
- •No severe debilitating pulmonary disease, including any of the following:
- •Dyspnea at rest
- •Significant shortness of breath
- •Chronic obstructive pulmonary disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 1 month after study participation
- •No known HIV positivity
- •No psychological or social condition that would preclude study compliance
- •No addictive disorder that would preclude study compliance
- •No family problems that would preclude study compliance
- •No known allergy or sensitivity to soy or other excipient components of study drug
- •No other illness or condition that may affect safety of study treatment or evaluation of study endpoints
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 2 weeks since prior interferon
- •No concurrent interferon
- •Chemotherapy
- •More than 2 weeks since prior cytarabine (4 weeks for doses > 100 mg)
- •More than 6 weeks since prior busulfan
- •No concurrent cytarabine
- •No concurrent hydroxyurea during the second study treatment course and beyond
- •No concurrent anagrelide during the second study treatment course and beyond
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •More than 2 days since prior imatinib mesylate
- 另有 32 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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