NCT00019227已完成1 期
PHASE I/II STUDY OF TAC-EXPRESSING ADULT T-CELL LEUKEMIA (ATL) WITH YTTRIUM-90 (90Y)-RADIOLABELED HUMANIZED ANTI-TAC AND CALCIUM-DTPA
适应症
相关药物
试验速览
- 阶段
- 1 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.
PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus pentetic acid calcium in patients with leukemia.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of yttrium Y 90 daclizumab (90Y daclizumab) when combined with pentetic acid calcium in adults with Tac-expressing T-cell leukemia.
- Determine the therapeutic efficacy and toxicity of this regimen in these patients.
- Monitor patients treated on this regimen for circulating infused antibody (free and labeled) and for the serum concentration of soluble interleukin-2 receptor.
- Evaluate, in a preliminary manner, the immunogenicity of daclizumab.
- Determine the effect of 90Y daclizumab on various components of the circulating cellular immune system.
- Determine whether there is additional urinary excretion of yttrium Y 90 when compared to that observed previously in patients treated without pentetic acid calcium.
OUTLINE: This is a dose escalation study of yttrium Y 90 daclizumab (90Y daclizumab).
Patients receive 90Y daclizumab IV over 2 hours on day 1 and a fixed dose of pentetic acid calcium IV over 5 hours for 3 days. Treatment repeats every 6 weeks for a maximum of 9 courses in the absence of disease progression or circulating antibodies to humanized anti-Tac.
Cohorts of 3-6 patients receive escalating doses of 90Y daclizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Additional patients are treated at the MTD.
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:
- •Histologically confirmed adult T-cell leukemia or lymphoma (ATL) of any stage
- •Tac expression of malignant cells confirmed by one of the following:
- •At least 10% of peripheral blood, lymph node, or dermal malignant cells reactive with anti-Tac by immunofluorescent staining
- •Soluble interleukin-2 receptor levels greater than 1,000 U/mL (normal geometric mean = 235; 95% confidence intervals = 112-502 U/mL)
- •Measurable disease required
- •More than 10% (i.e., strongly Tac-expressing) abnormal cells in peripheral blood considered measurable disease
- •All stages of Tac-expressing adult T-cell leukemia are eligible
- •Smoldering ATL patients are eligible only if the symptoms and sites of involvement by ATL are such that there is a medical indication to treat
- •Smoldering ATL, defined as:
- •Lymphocyte count less than 4,000/mm^3
- •Less than 5% abnormal lymphocytes on morphologic exam of peripheral blood
- •No hypercalcemia
- •Lactate dehydrogenase no greater than 1.5 times normal
- •No lymphadenopathy
- •No involvement of extranodal organs except skin or lung
- •No malignant pleural effusion or ascites
- •No symptomatic CNS disease due to ATL
- •Concurrent diagnosis of tropical spastic paraparesis allowed
- •No detectable levels (i.e., greater than 250 ng/mL) of antibody to study drug as assessed by ELISA
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Not specified
- •Life expectancy:
- •Greater than 2 months
- •Hematopoietic:
- •Absolute granulocyte count at least 1,000/mm^3
- •Platelet count at least 75,000/mm^3
- •Bilirubin less than 2.0 mg/dL (unless directly due to ATL)
- •AST/ALT less than 2.5 times normal
- •Creatinine less than 1.5 mg/dL OR
- •Creatinine clearance greater than 35 mL/min
- •Cardiovascular:
- •No clinical cardiac failure
- •No symptomatic pulmonary dysfunction unless due to underlying malignancy
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •At least 4 weeks since prior cytotoxic chemotherapy
- •Endocrine therapy
- •Concurrent corticosteroids allowed
- •Radiotherapy
- •Not specified
- •Not specified
- •Not specified
排除标准
- 未提供
研究者
研究点 (1)
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