NCT00886496撤回1 期
A Multi-Center Study of the Safety, Tolerability, Pharmacokinetics and Dose Escalation of Intravenous Recombinant Human Mannose-Binding-Lectin (rhMBL) in MBL Deficient Pediatric Hematology/Oncology Patients With Fever and Neutropenia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Efficacy
研究概览
简要总结
RATIONALE: Recombinant human mannose-binding lectin (MBL) may be effective in preventing infection in young patients with fever and neutropenia receiving chemotherapy for blood disease or cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of recombinant human mannose-binding lectin in treating young patients with MBL deficiency and fever and neutropenia.
详细描述
OBJECTIVES:
Primary
- Determine the safety and tolerability of recombinant human mannose-binding lectin (MBL) in pediatric patients with MBL deficiency and fever and neutropenia who are undergoing cytotoxic chemotherapy for hematological/oncological disease.
- Determine the pharmacokinetics of this drug in these patients.
Secondary
- Determine the pharmacodynamic effect of this drug in these patients.
- Determine nonspecific activation of complement by in vivo determination of C3d complement activation in patients treated with this drug.
- Determine the ex-vivo activity of recombinant MBL in opsonization capacity of patients' sera to yeast and bacteria.
- Determine immunogenicity of this drug in these patients.
- Determine the incidence and duration of fever and breakthrough infections in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Supportive Care
- 盲法
- None
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:
- •Undergoing cytologic chemotherapy for hematological/oncological disease
- •Must meet all of the following criteria:
- •Documented mannose-binding lectin (MBL) levels < 300 ng/mm³ within the past week
- •Fever (oral temperature > 100.4° F)
- •Neutropenia, defined as absolute neutrophil count ≤ 1,000/mm³ with the anticipation that the counts will fall below 500/mm^3
- •Receiving broad spectrum antibiotic therapy for fever and neutropenia
- •PATIENT CHARACTERISTICS:
- •No serious illness, in the opinion of the principal investigator, that would preclude study compliance
- •No known allergic reactions to mannose-binding lectin or other human plasma products
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier method contraception during and for ≥ 30 days after completion of study treatment
- •AST and ALT ≤ 5 times upper limit of normal (ULN)
- •Bilirubin ≤ 2.5 times ULN
- •Creatinine clearance > 60 mL/min OR creatinine based on age as follows:
- •No more than 0.8 mg/dL (for patients 5 years of age and under)
- •No more than 1.0 mg/dL (for patients 6-9 years of age)
- •No more than 1.2 mg/dL (for patients 10-12 years of age)
- •No more than 1.4 mg/dL (for patients over 13 years of age [female])
- •No more than 1.5 mg/dL (for patients 13-15 years of age [male])
- •No more than 1.7 mg/dL (for patients of 16 years of age [male])
- •No poor venous access that would preclude IV drug delivery or multiple blood draws
- •Patients on hemodialysis must be able to tolerate IV fluid on non-dialysis days
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 30 days since prior investigational agents
- •Investigational use of an FDA-approved drug allowed
- •No concurrent preparative regimen for a bone marrow or hematopoietic stem cell transplantation
- •No concurrent participation in another clinical trial with an investigational agent
排除标准
- 未提供
结局指标
主要结局
Efficacy
Pharmacokinetics
Toxicity
次要结局
未报告次要终点
研究者
研究点 (3)
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