NCT00041379Unknown1 期
Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Waldenstrom's Macroglobulinemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients who have Waldenstrom's macroglobulinemia.
详细描述
OBJECTIVES:
- Determine the antitumor effects of low-dose beta alethine in patients with Waldenstrom's macroglobulinemia.
- Determine the effects of this drug on anemia, performance status, and disease symptoms in these patients.
- Determine the effects of this drug on the immune system of these patients.
- Determine the safety of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive beta alethine subcutaneously on days 1, 15, 29, 43, 57, and 71. Courses repeat every 85 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for 30 days.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Confirmed diagnosis of Waldenstrom's macroglobulinemia
- •Urine or serum protein electrophoresis showing a measurable monoclonal spike
- •Indolent disease not yet requiring therapy allowed
- •Positive delayed-type hypersensitivity (DTH) response
- •Induration greater than 2 mm for at least 1 antigen
- •No clinical signs or evidence of active brain involvement or leptomeningeal disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 50-100%
- •Life expectancy:
- •At least 4 months
- •Hematopoietic:
- •Neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin at least 10 g/dL
- •Albumin at least 3.5 g/dL
- •Bilirubin less than 2.0 mg/dL
- •Transaminases no greater than 2.5 times upper limit of normal
- •Creatinine no greater than 2.0 mg/dL
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No acute changes on EKG
- •No uncontrolled angina
- •No heart failure
- •No arrhythmia
- •Adequate nutritional intake as evidenced by total protein at least 60 g/L
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No concurrent gastrointestinal bleed
- •No active bacterial infections such as abscess or with fistulae
- •HIV negative
- •No other concurrent non-malignant disease that would preclude study
- •No history of alcoholism, drug addiction, or psychotic disorders that would preclude follow-up
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •More than 4 weeks since prior immunotherapy
- •More than 4 weeks since prior cytokines
- •More than 4 weeks since prior plasmapheresis or plasma exchange
- •No prior stem cell or bone marrow transplant
- •Chemotherapy:
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high-dose carboplatin)
- •No prior intensive chemotherapy with stem cell support
- •Endocrine therapy:
- •More than 4 weeks since prior corticosteroids
- •No concurrent corticosteroids
- •Radiotherapy:
- •More than 4 weeks since prior radiotherapy involving more than 25% of bone marrow
- •Recovered from any prior surgery
- 另有 4 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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