NCT00001271已完成1 期
A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
研究概览
简要总结
Patients with CD22(+) B-cell lymphomas will be treated with escalating doses as a 192 hr infusion of immunotoxin in a Phase I study to determine dose limiting toxicity evidence of response.
详细描述
Patients with CD22(+) B-cell lymphomas will be treated with escalating doses as a 192 hr infusion of immunotoxin in a Phase I study to determine dose limiting toxicity evidence of response.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a histologic diagnosis confirmed from a pretreatment biopsy at the Laboratory of Pathology, NCI of one of the following entities: Diffuse small Lymphocytic Lymphoma; Follicular, Small Cleaved cell Lymphoma; Follicular, Mixed Small Cleaved and Large Cell Lymphoma; Follicular Large Cell Lymphoma; Diffuse, Intermediately Differentiated Lymphocytic Lymphoma; Diffuse, Small Cleaved Cell Lymphoma; Diffuse, Mixed Small and Large Cell Lymphoma; Diffuse, Large Cell Lymphoma; Large Cell Immunoblastic Lymphoma; Small Noncleaved Cell Lymphoma.
- •Presence of CD22 antigen on at least 30 percent of tumor cells.
- •Presence of objectively measurable sites of disease. Bone marrow positivity and circulating tumor cells in the peripheral blood will be considered evaluable but not measurable disease.
- •No patients with purely B-cell Lymphosarcoma cell leukemia without nodal or soft tissue involvement.
- •No patients with B-cell chronic lymphocytic leukemia, or B-cell or pre-B-cell acute lymphocytic leukemia, and hairy cell leukemia.
- •Patients with objectively measurable disease outside a radiation port or disease which has clearly progressed within a radiation port.
- •HIV negative.
- •No CNS disease.
- •No pulmonary parenchymal disease.
- •Pleural effusions or ascites may be present.
- •Patients with progression of disease despite at least one standard combination chemotherapy regimen.
- •No chemotherapy for at least two weeks prior to entry.
- •Patients who do not desire or are not candidates for autologous or allogeneic bone marrow transplantation procedures.
- •Life expectancy of at least 3 months
- •Creatinine clearance greater than 60 cc per minute.
- •Total bilirubin less than 1.5 mg/dl.
- •SGPT less than 2 times the upper limit of normal.
- •Albumin greater than 75 percent of the lower limit of normal.
- •If prior treatment with doxorubicin, the radionuclide or echocardiogram ejection fraction shall be at least 35 percent.
- •Performance status 0-
- •Not in need of current radiation therapy to alleviate local problems.
- •No prior exposure to murine antibodies.
- •No need for current corticosteroid treatment.
排除标准
- 未提供
研究者
研究点 (1)
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