NCT00020527已完成不适用
A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children With New Onset Fever and Neutropenia
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 5
研究概览
简要总结
RATIONALE: Giving caspofungin acetate may be effective in preventing or controlling fever and neutropenia caused by chemotherapy or bone marrow transplantation.
PURPOSE: Clinical trial to study the effectiveness of caspofungin acetate in treating children who have fever and neutropenia caused by a weakened immune system.
详细描述
OBJECTIVES:
- Determine the pharmacokinetics and serum levels of caspofungin acetate in immunocompromised children with new-onset fever and neutropenia.
- Determine the safety and tolerability of this drug in this patient population.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to age (2 to 11 vs 12 to 17).
Patients receive caspofungin acetate IV over 1 hour once daily for 4 to 28 days in the absence of the need to start standard empirical antifungal therapy, a breakthrough fungal infection, any deterioration of patient condition, or unacceptable toxicity.
Cohorts of 16 patients (8 per stratum) receive caspofungin acetate at 1 of 2 dose levels. Caspofungin acetate is escalated to dose level 2 if no more than 1 of 8 patients experiences dose-limiting toxicity at dose level 1.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Immunocompromised with one or more of the following conditions:
- •Leukemia, lymphoma, or other cancer
- •Underwent bone marrow or peripheral blood stem cell transplantation
- •Aplastic anemia
- •Planned chemotherapy likely to incur more than 10 days of neutropenia
- •Absolute neutrophil count no greater than 500/mm^3 AND at least 1 recorded fever over 38.0 ° C within 24 hours of study
- •No proven invasive fungal infection at time of study entry
- •Superficial fungal infection (e.g., cutaneous fungal infection, thrush, or candidal vaginitis) treatable with topical antifungals allowed
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •At least 5 days
- •Hematopoietic:
- •See Disease Characteristics
- •Hemodynamically stable with no hemodynamic compromise
- •AST or ALT no greater than 3 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 5 times ULN (unless related to bony metastases or other suspected bony processes)
- •INR no greater than 1.6 (4.0 if receiving anticoagulants)
- •No acute hepatitis or cirrhosis
- •Not specified
- •Functioning central venous catheter in place
- •No other condition or concurrent illness that would preclude study
- •No prior allergy, hypersensitivity, or serious reaction to echinocandin antifungals
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception other than or in addition to oral contraceptives
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •No prior enrollment into this study
- •No more than 48 hours since prior parenteral systemic antibacterial therapy for fever and neutropenia
- •At least 14 days since prior investigational antibiotic or antifungal drugs
- •Concurrent topical antifungals (i.e., nystatin and/or azole formulations) for a superficial fungal infection allowed
- •No other concurrent investigational drugs, including antibiotics or antifungals
- •No concurrent rifampin, cyclosporine, phenytoin, carbamazapine, phenobarbital, or other antifungal treatments (except fluconazole)
排除标准
- 未提供
研究者
研究点 (5)
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