NCT00587015终止1 期
A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Assess safety, estimate MTD, characterize toxicity profile, study pharmacology and observe anti-tumor activity at the MTD.
研究概览
简要总结
A dose-escalation study to estimate the maximum tolerated dose(MTD) of CAT-8015 that can be safely administered to a patient.
详细描述
To estimate the maximum tolerated dose (MTD), defined as the highest dose that can be safely administered to a patient, and to establish a safe dose, based on MTD, for subsequent clinical testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria to be eligible to participate in the study:
- •Confirmed diagnosis of B-cell non-Hodgkin's lymphoma
- •Measurable disease
- •Evidence of CD22-positive malignancy by the following criteria, > 30% of malignant cells from a disease site CD22+ by FACS analysis or, > 15% of malignant cells from a disease site must react with anti-CD22 by immunohistochemistry
- •Disease characteristics: Patients with indolent subtypes of CD22+ B-cell non- Hodgkin's lymphoma, including, but not limited to mantle cell lymphoma, follicular lymphoma and Waldenström's macroglobulinemia, are eligible if stage III-IV. if stage III-IV. Patients must have failed at least two or more courses of prior standard chemotherapy and/or biologic therapy (e.g. Rituxan). Patients with progressive mantle cell lymphoma may be eligible if they have failed one prior standard therapeutic regimen.
- •ECOG performance status of 0-2
- •Patients with other cancers who meet eligibility criteria and have less than 5 years of disease free survival will be considered on a case-by-case basis
- •Life expectancy of less than 6 months, as assessed by the principal investigator
- •Must be able to understand and sign informed consent
- •Must be at least 18 years old
- •Female and male patients must agree to use an approved method of contraception during the study
排除标准
- •Subjects meeting any of the following criteria are not eligible for participation in the study:
- •History of allogeneic bone marrow transplant
- •Documented and ongoing central nervous system involvement with their malignant disease (history of CNS involvement is not an exclusion criterion)
- •Pregnant or breast-feeding females
- •HIV positive serology (due to increased risk of severe infection and unknown interaction of CAT-8015 with antiretroviral drugs)
- •Hepatitis B surface antigen positive
- •Uncontrolled, symptomatic, intercurrent illness including but not limited to: infections requiring systemic antibiotics, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements
- •Patients whose plasma contains either a significant level of antibody to CAT-8015 as measured by ELISA, or antibody that neutralizes the binding of CAT-8015 to CD22 as measured by a competition ELISA.
- •Hepatic function Serum transaminases (either ALT or AST) or bilirubin:
- •≥ Grade 2, unless bilirubin is due to Gilbert's disease
- •Renal function:
- •serum creatinine clearance ≤ 60mL/min as estimated by Cockroft-Gault formula
- •Hematologic function:
- •The ANC < 1000/cmm, or platelet count <50,000/cmm, if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy).
- •A patient will not be excluded because of pancytopenia ≥ Grade 3, or erythropoietin dependence, if it is due to disease, based on the results of bone marrow studies
- •Baseline coagulopathy greater than or equal to Grade 3 unless due to anticoagulant therapy.
- •Pulmonary function:
- •Patients with < 50% of predicted forced expiratory volume (FEV1) or <50% of predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin concentration and alveolar volume. Note: Patients with no prior history of pulmonary illness are not required to have PFTs. FEV1 will be assessed after bronchodilator therapy.
- •Recent prior therapy:
- •Cytotoxic chemotherapy, corticosteroids (except stable doses of prednisone), whole body electron beam radiation therapy, hormonal, biologic or other standard or any investigational therapy of the malignancy for 3 weeks prior to entry into the trial
- •Less than or equal to 1 month prior monoclonal antibody therapy (i.e. rituximab)
- •Patients who are receiving or have received radiation therapy less than 3 weeks prior to study entry will be not be excluded providing the volume of bone marrow treated is less than 10% and also the patient has measurable disease outside the radiation port
- •Any history of prior pseudomonas-exotoxin immunotoxin (PE) administration.
研究组 & 干预措施
1
Active Comparator
CAT-8015
干预措施: CAT-8015 (Drug)
结局指标
主要结局
Assess safety, estimate MTD, characterize toxicity profile, study pharmacology and observe anti-tumor activity at the MTD.
时间窗: Day 28
次要结局
- Assess immunogenicity of CAT 8015 and potential biomarkers for therapeutic or toxicity responses.(Day 0-7; 0-14)
研究者
研究点 (3)
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