NCT00526318Unknown不适用
Trial Protocol for the Treatment of Children With High Risk Neuroblastoma (NB2004-HR)
German Society for Pediatric Oncology and Hematology GPOH gGmbH135 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2007年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 360
- 试验地点
- 135
- 主要终点
- Event-free survival (EFS)
研究概览
简要总结
RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or by killing them. It also prepares the patient's bone marrow for the stem cell transplant. The stem cells are given to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving isotretinoin after transplant may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given before a stem cell transplant and isotretinoin in treating neuroblastoma.
PURPOSE: This randomized clinical trial is studying two different combination chemotherapy regimens to compare how well they work when given before a stem cell transplant and isotretinoin in treating young patients with high-risk neuroblastoma.
详细描述
OBJECTIVES:
Primary
- Compare the event-free survival of pediatric patients with high-risk neuroblastoma treated with standard induction chemotherapy vs topotecan hydrochloride-containing induction chemotherapy followed by myeloablative autologous stem cell transplantation and consolidation therapy with isotretinoin.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare early response (complete response, very good partial response, partial response, mixed response, stable disease, and progression/relapse) after 2 courses of standard vs experimental induction chemotherapy (or after 60 days if the second course is not yet finished).
- Compare response to standard vs experimental induction chemotherapy before autologous stem cell transplantation (or after 280 days if induction chemotherapy is not yet finished).
- Compare the toxicity of standard vs experimental induction chemotherapy during courses 1 and 2 and the frequency of ≥ grade 3 toxicity during the last 6 courses of induction chemotherapy.
- Compare the extent of initial surgery and best surgery (biopsy vs incomplete resection vs macroscopic complete resection) and the frequency of complications related to surgery (e.g., nephrectomy, bleeding, infection, or intestinal obstruction).
- Compare the acute and long-term side effects of external-beam radiotherapy.
- Correlate the activity of MIBG and whole-body radiation dose.
- Collect and store tumor material in the tumor bank for future evaluation of other molecular markers (MYCN and status of chromosome 1p and 11q) and prognostic significant gene signatures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of neuroblastoma according to any of the following criteria:
- •Histological diagnosis from tumor tissue
- •Presence of distinct neuroblastoma cells in the bone marrow and elevated catecholamine metabolites (HVA, VMA) in blood or urine
- •High-risk disease, meeting 1 of the following criteria:
- •Stage 4 disease, regardless of the MYCN status (1-21 years of age)
- •Stage 1-3 or 4S disease with MYCN amplification (6 months -21 years of age)
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Fertile patients must use effective contraception (hormonal contraception or intra-uterine device [IUD])
- •PRIOR CONCURRENT THERAPY:
- •No concurrent participation in another clinical trial that would preclude the interventions or outcome assessment of this clinical trial
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Event-free survival (EFS)
次要结局
- Early response, measured after 2 courses of induction chemotherapy
- Impact of the extent of initial and best surgery on outcome and frequency of complications
- Acute and late toxicity of radiotherapy
- Molecular markers (MYCN and status of chromosome 1p and 11q)
- Response to induction therapy, measured before autologous stem cell transplantation
- Correlation of MIBG activity with whole-body radiation dose
- Overall survival (OS)
- Impact of well established clinical and molecular risk factors on EFS and OS
- Toxicity during the first 2 courses and the last 6 courses of induction chemotherapy
研究者
研究点 (135)
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