NCT00007956已完成1 期
A Phase I Study Of Therapy With Mono-dgA-RFB4 In Patients With Relapsed And Refractory CD22+ B-Cell Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent or refractory lymphoma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of monoclonal antibody mono-dgA-RFB4 in patients with recurrent or refractory B-cell lymphoma expressing CD22 antigen.
- Determine the pharmacokinetic profile of this drug in these patients.
- Correlate the pharmacokinetic parameters with the biologic effects and/or toxicity of this drug in these patients.
- Determine whether clinical responses in these patients occur at lower, equal, or higher doses than historical responses induced by a similar drug.
OUTLINE: This is a dose-escalation study. Patients are stratified according to number of circulating tumor cells in peripheral blood (more than 50/mm3 vs 50/mm3 or less).
Patients receive monoclonal antibody Mono-dgA-RFB4 IV over 4 hours on days 1, 3, and 5. Patients achieving complete, partial, or minimal remission receive additional courses of therapy every 4 weeks in the absence of unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody mono-dgA-RFB4 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
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 recurrent or refractory B-cell lymphoma after at least 1 standard chemotherapy regimen
- •Low, intermediate, or high grade
- •CD22 antigen on at least 30% of tumor cells by flow cytometry
- •No lymphoblastic lymphoma, B-cell chronic lymphocytic leukemia, B-cell or pre-B-cell acute lymphocytic leukemia, or hairy cell leukemia
- •Measurable disease
- •Positive bone marrow not considered measurable
- •Circulating tumor cells in peripheral blood considered measurable
- •No CNS disease (leptomeningeal or parenchymal)
- •No lymphomatous or infectious pulmonary parenchymal disease
- •No baseline/pleural effusion
- •Ineligible for or refused autologous or allogeneic bone marrow transplantation NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Platelet count greater than 50,000/mm^3
- •Absolute granulocyte count greater than 750/mm^3
- •Bilirubin less than 1.5 mg/dL
- •SGPT less than 2 times upper limit of normal
- •Albumin greater than 75% lower limit of normal
- •Creatinine no greater than 1.4 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •Ejection fraction greater than 40% by MUGA or echocardiogram
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No human anti-mouse antibody (HAMA) levels greater than 1 microgram/mL
- •No condition that may require stenting of ureters, stabilization of impending pathological fractures, or relief of airway, bowel, or biliary tract obstruction
- •No other concurrent illness that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •See Disease Characteristics
- •At least 2 weeks since prior chemotherapy and recovered
- •No concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent corticosteroids unless receiving stable maintenance dose prior to therapy
- •Radiotherapy:
- •No prior radiotherapy
- •No concurrent radiotherapy
- •Not specified
- •No other concurrent investigational agents
排除标准
- 未提供
研究者
研究点 (2)
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