Monoclonal Antibody 3F8 and Oral Etoposide for 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: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus etoposide in treating patients who have neuroblastoma.
详细描述
OBJECTIVES:
- Determine the antitumor effects of monoclonal antibody 3F8, etoposide, and isotretinoin using standard imaging methods and tumor marker studies in patients with high-risk neuroblastoma.
- Assess progression-free survival in these patients after this treatment.
- Assess the effects of oral etoposide on human anti-mouse antibody and anti-idiotype response in these patients.
OUTLINE: Patients are stratified according to disease status (evaluable but not measurable vs second or subsequent remission with no measurable or evaluable disease).
Patients receive monoclonal antibody 3F8 (MOAB 3F8) IV over 1.5 hours once daily on days 1-10 and oral etoposide once daily on days 29-49. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression, human anti-mouse antibody (HAMA) response, or unacceptable toxicity.
If HAMA fails to develop after completion of 4 courses of MOAB 3F8, patients continue treatment with MOAB 3F8 on days 1-5 every 8 weeks until HAMA reaches greater than 1,000 U/mL or until month 24, whichever occurs first.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •High-risk neuroblastoma by:
- •Histopathology OR
- •Bone marrow involvement plus elevated urinary catecholamines
- •Prior tumor progression on standard chemotherapy and poor long-term prognosis as indicated by 1 or more of the following:
- •N-myc amplification in tumor cells
- •Diploid chromosomal content plus lp loss of heterozygosity in tumor cells
- •Distant skeletal metastases
- •Unresectable primary tumor infiltrating across the midline
- •More than 10% tumor cells in bone marrow
- •Less than 30% chance of long-term progression-free survival
- •Evaluable (microscopic marrow metastasis, elevated tumor markers, abnormal bone scan or MIBG or PET scan) but not measurable (CT scan, MRI) disease documented at least 4 weeks after completion of prior systemic therapy
- •No rapidly progressive disease as defined by 1 or more of the following:
- •Serum lactic dehydrogenase greater than 1.5 times upper limit of normal due to tumor
- •An opiate requirement for pain from tumor
- •Greater than 25% increase in tumor by successive imaging studies
- •Life expectancy less than 8 weeks
- •Second or subsequent remission after chemotherapy and/or radiotherapy allowed provided there is less than 30% chance of survival
- •No prior myelodysplastic syndromes or leukemia
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •See Disease Characteristics
- •At least 8 weeks
- •Hematopoietic:
- •Not specified
- •No grade 3 or worse liver toxicity
- •No grade 3 or worse renal toxicity
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No grade 3 or worse cardiac toxicity
- •No grade 3 or worse pulmonary toxicity
- •Not pregnant
- •No grade 3 or worse gastrointestinal toxicity
- •No grade 3 or worse neurologic system toxicity
- •No grade 4 hearing deficit
- •No active life-threatening infection
- •No prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 ELISA units/mL
- •No allergy to mouse proteins
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- 另有 1 项未显示
排除标准
- 未提供