Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU in Patients With Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma.
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 more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining O6-benzylguanine with carmustine in treating patients who have previously untreated, refractory, or relapsing multiple myeloma.
详细描述
OBJECTIVES:
- Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma.
- Assess the effects of O6-benzylguanine on bone marrow myeloma cells in this patient population.
OUTLINE: Patients receive O6-benzylguanine IV over 60 minutes followed 1 hour later by carmustine IV over 60 minutes. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond attainment of best response (partial or complete response or stable or plateau disease).
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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:
- •Histologically confirmed progressive multiple myeloma, meeting 1 of the following criteria:
- •Previously untreated
- •Primary refractory
- •Relapsing disease
- •Major criteria:
- •Plasmacytomas on tissue biopsy
- •Bone marrow plasmacytosis with greater than 30% plasma cells
- •Monoclonal globulin spike on serum electrophoresis
- •Greater than 3.5 g/dL for G peaks or greater than 2.0 g for A peaks
- •Greater than 1.0 g/24 hours of kappa or lambda light chain excretion on urine electrophoresis in the absence of amyloidosis
- •Minor criteria:
- •10%-30% bone marrow plasmacytosis (criterion A)
- •Presence of monoclonal globulin spike but less than the levels under major criteria (criterion B)
- •Lytic bone lesions (criterion C)
- •IgM less than 50 mg/dL, IgA less than 100 mg/dL, or IgG less than 600 mg/dL (criterion D)
- •Must meet one of the following:
- •A minimum of 1 major criterion and 1 minor criterion
- •3 minor criteria, including criteria A and B
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •WBC greater than 3,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Absolute neutrophil count greater than 1,500/mm^3
- •Hemoglobin greater than 9 g/dL (transfusions allowed)
- •Bilirubin less than 1.5 mg/dL
- •AST/ALT less than 2 times normal
- •Creatinine no greater than 2.0 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Calcium less than 14 mg/dL
- •No prior or concurrent active, symptomatic respiratory disease
- •Corrected DLCO at least 60% predicted
- •Controlled diabetes mellitus allowed
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 2 months after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No more than 1 prior chemotherapy regimen containing an alkylating agent for multiple myeloma
- •At least 4 weeks since prior chemotherapy
- •Endocrine therapy:
- •Prior corticosteroids for multiple myeloma allowed
- •Radiotherapy:
- •No prior pelvic radiotherapy or radiotherapy to more than 25% of bone marrow
- 另有 1 项未显示
排除标准
- 未提供
结局指标
主要结局
Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma.
时间窗: Every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond attainment of best response. Patients are followed every 2 months.
次要结局
未报告次要终点