NCT00028613已完成1 期
Phase I Safety Study Of 131I-Lym-1 For The Treatment Of Previously Treated Diffuse Large B-Cell Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances such as radioactive iodine to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibodies in treating patients who have large cell lymphoma that has been previously treated.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of iodine I 131 monoclonal antibody Lym-1 in patients with previously treated diffuse large cell lymphoma.
- Determine the safety of this drug in these patients.
- Determine the response of patients to this drug.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive unlabeled monoclonal antibody Lym-1 IV over 40 minutes followed 15-30 minutes later by iodine I 131 monoclonal antibody Lym-1 IV over 2 minutes.
Cohorts of 3-6 patients receive escalating doses of iodine I 131 monoclonal antibody Lym-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
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
- 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
- •Histologic diagnosis of B-cell diffuse large cell lymphoma (REAL classification system) confirmed by an independent central pathology reviewer.
- •The tumor's B-cell phenotype will be confirmed by positive L-26 (CD20).
- •Previous treatment with 2 common combination chemotherapy regimens. Patients previously treated with unlabeled monoclonal antibody therapy are eligible.
- •Men or women at least 18 years of age.
- •Karnofsky Performance Score (KPS) estimated to be > 60 at the time of the scheduled therapeutic dose of 131I-Lym-
- •Life expectancy estimated to be at least 3 months from the time of the therapeutic dose of 131I Lym-
- •Measurable disease demonstrable by physical examination or computerized tomography (CT).
- •CT scan evidence of at least one indicator lesion with at least one diameter that measures > 2 cm. (The CT scan should be done within 2 weeks of the imaging study.)
排除标准
- •Inability or unwillingness to comply with the following:
- •Bone marrow biopsy
- •Return for follow-up visits
- •Remaining motionless for extended periods of time for imaging procedures
- •Serial blood/urine sampling (for dosimetry patients only)
- •Pregnancy (Women of childbearing potential must be practicing an effective method of contraception.)
- •Presence of a second malignancy except for basal cell skin carcinoma or carcinoma in-situ of the cervix
- •Presence of active lymphomatous meningitis or other CNS involvement with lymphoma.
- •HIV positive patients.
- •Prior total body irradiation, or a course of prior radiation > 3,000 cGy delivered to > 20% of the central marrow or the lumbar vertebrae within 6 months of screening.
- •Serum creatinine or total bilirubin > 2 x the upper limit of normal.
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase > 3 x the upper limit of normal.
- •Significant marrow lymphoma (defined as lymphoma cells constituting greater than 20% of the hematopoietic marrow elements from an iliac crest biopsy). A prior bone marrow biopsy is acceptable if it meets the following criteria:
- •If there is prior bone marrow involvement, the biopsy must be performed within 45 days of screening.
- •If there is no prior bone marrow involvement, the biopsy must be performed within 90 days of screening
- •WBC count < 3,500/mm3, granulocyte count < 1,500/mm3, or platelet count < 125,000/mm
- •Positive human anti-mouse antibodies (HAMA) serum values, defined as > 74 ng/mL at screening.
- •Patients who have not recovered from toxicities of most recent anti-lymphoma therapy.
- •Treatment with:
- •Colony stimulating factor G-CSF or GM-CSF within 120 hours of screening laboratory assessment.
- •Erythropoietin (EPO) within a month of screening laboratory assessment
- •Whole blood or platelet transfusion within 120 hours of screening laboratory assessment
- •History or electrocardiographic (ECG) evidence of Q-wave myocardial infarction within 6 months of screening or congestive heart failure (CHF; NYHA Stage III or IV).
- •Known hypersensitivity to iodine or iodine-containing organic substances.
- •Patients who require therapy with anticoagulants or antiplatelet drugs which cannot be discontinued during the study.
- •Patients who are known to have antiplatelet antibodies.
研究者
研究点 (1)
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