NCT00093353已完成1 期
A Phase I Study Of Oral Irinotecan, Temozolomide, Cefixime In Children With Recurrent/Resistant High-Risk Neuroblastoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 21
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Temozolomide may help irinotecan kill more tumor cells by making them more sensitive to the drug. Cefixime may be effective in preventing diarrhea that is caused by treatment with irinotecan.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and cefixime in treating young patients with recurrent or resistant neuroblastoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of oral irinotecan when administered with fixed-dose temozolomide and cefixime in pediatric patients with recurrent or resistant high-risk neuroblastoma.
- Determine the toxic effects of this regimen in these patients.
Secondary
- Determine the response rate in patients treated with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
- Correlate UGT1A1 genotype with the occurrence of dose-limiting diarrhea in patients treated with this regimen.
- Correlate BCRP genotype with pharmacokinetic phenotype in patients treated with this regimen.
- Correlate p53 status in tumor cells with response in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 1 Year 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed neuroblastoma AND/OR demonstration of tumor cells in the bone marrow with increased urinary catecholamines
- •High-risk disease meeting 1 of the following criteria:
- •Recurrent or progressive disease
- •Resistant or refractory disease (i.e., never achieved a complete response to therapy AND never had new sites of disease or progression of initial sites)
- •Measurable disease meeting at least 1 of the following criteria:
- •Unidimensionally measurable tumor ≥ 20 mm by MRI, CT scan, or x-ray OR ≥ 10 mm by spiral CT scan*
- •At least 1 site with positive uptake by metaiodobenzylguanidine (MIBG) scan*
- •Bone marrow with tumor cells seen on routine morphology (not by NSE staining only) of bilateral aspirate AND/OR biopsy on 1 bone marrow sample NOTE: *Patients who never experienced disease recurrence or progression must demonstrate viable neuroblastoma in a biopsy of either bone marrow or bone and/or soft tissue site (biopsy must be performed ≥ 4 weeks after completion of prior radiotherapy if lesion was irradiated)
- •PATIENT CHARACTERISTICS:
- •1 to 30 at diagnosis
- •Performance status
- •Life expectancy
- •At least 2 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 750/mm^3
- •Platelet count ≥ 75,000/mm^3 (without transfusion)
- •Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
- •SGPT and SGOT < 5 times normal
- •Bilirubin ≤ 1.5 times normal
- •Creatinine ≤ 1.5 times normal for age
- •No greater than 0.8 mg/dL (≤ 5 years of age)
- •No greater than 1.0 mg/dL (6 to 10 years of age)
- •No greater than 1.2 mg/dL (11 to 15 years of age)
- •No greater than 1.5 mg/dL (> 15 years of age)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No allergy to cephalosporins
- •No active diarrhea
- •No uncontrolled infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Chemotherapy
- •Recovered from prior immunotherapy
- •More than 3 weeks since prior biologic therapy and recovered
- •More than 2 days since prior hematopoietic growth factors
- •No concurrent epoetin alfa
- •No concurrent prophylactic hematopoietic growth factors during the first treatment course
- •No concurrent immunomodulating agents except steroids to control intracranial pressure
- •Chemotherapy
- •Prior myeloablative therapy and autologous stem cell transplantation allowed
- •No prior allogeneic stem cell transplantation
- •More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
- •Prior temozolomide, irinotecan, or topotecan allowed
- •No prior temozolomide and irinotecan as combination therapy
- •No other concurrent chemotherapy
- •Endocrine therapy
- •See Biologic therapy
- •Radiotherapy
- 另有 7 项未显示
排除标准
- 未提供
研究者
研究点 (21)
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