N8: Dose-Intensive Chemotherapy Plus Biologics in the Treatment of Neuroblastoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Combining different types of therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy, monoclonal antibody therapy, surgery, peripheral stem cell transplantation, radiation therapy, and biological therapy in treating patients who have advanced neuroblastoma.
详细描述
OBJECTIVES:
- Determine whether treatment with multimodality therapy comprising dose-intensive induction chemotherapy, monoclonal antibody 3F8, surgery, myeloablative chemotherapy, autologous or syngeneic bone marrow or peripheral blood stem cell transplantation, radiotherapy, and isotretinoin improves the cure rate in patients with advanced neuroblastoma.
- Determine whether the 2-year progression-free survival (PFS) rate improves to 70% in patients with newly diagnosed advanced neuroblastoma treated with this regimen.
- Determine whether the 2-year PFS rate improves to 40% in patients with previously treated advanced neuroblastoma treated with this regimen.
- Determine the biologic and clinical prognostic factors of neuroblastoma that may guide future research of treatment approaches for this malignancy.
OUTLINE: Patients are stratified according to the following:
- Stratum 1: Patients with previously untreated stage IV disease who are over age 1 at diagnosis, with or without N-myc amplification
- Stratum 2: Patients with previously treated stage IV disease who are over age 1 at diagnosis; or patients with previously treated high-risk disease (e.g., N-myc amplified stage III or IV disease, under age 1 at diagnosis, and with or without prior treatment)
- Intensive induction therapy (courses 1-5): During courses 1, 2, and 4, patients receive cyclophosphamide IV over 6 hours on days 1 and 2 and doxorubicin and vincristine IV continuously on days 1-3. Courses repeat every 21 days. During courses 3 and 5, patients receive etoposide (VP-16) IV over 2 hours on days 1-3 and cisplatin IV over 1 hour on days 1-4. Courses repeat every 35 days. Before proceeding to myeloablative therapy/transplantation, patients in stratum 2 must have received a minimum of 2 courses of chemotherapy if they achieved a complete response (CR) or very good partial response (VGPR) or patients must have received a minimum of 3 courses of chemotherapy if they achieved less than a CR or VGPR.
Patients undergo tumor resection either at diagnosis or after completion of a minimum of 3 courses of chemotherapy (approximately day 63).
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
- — 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of neuroblastoma by 1 of the following:
- •Histologic confirmation, including immunohistochemical, ultrastructural, or cytogenetic studies
- •Elevated urinary catecholamines plus tumor cells/clumps in the bone marrow
- •Poor-risk disease, defined by 1 of the following:
- •Stage IV disease
- •Unresectable primary disease plus N-myc amplification
- •Infant (under age 1) with stage IV disease plus N-myc amplification
- •Previously treated disease allowed
- •PATIENT CHARACTERISTICS:
- •50 and under
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No prior allergy to mouse proteins
- •Not pregnant
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior murine antibodies allowed if human anti-mouse antibody (HAMA) titer is less than 1,000 ELISA units/mL
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
排除标准
- 未提供