NCT00515892Unknown1 期
A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin'd Lymphoma (NHL)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Estimate the maximum dose that can be safely administered to a patient; Characterize the toxicity profile of CAT-8015; Study the clinical pharmacology of CAT-8015; Observe anti-tumor activity, if any.
研究概览
简要总结
RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be effective treatment for Non-Hodgkin's lymphoma (NHL) that has not responded to chemotherapy, surgery or radiation therapy.
PURPOSE: Phase 1 dose escalation study to determine the maximum tolerated dose of CAT-8015 immunotoxin in treating patients who have Non-Hodgkin's lymphoma and do not respond to treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •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
- •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.
- •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.
- •PATIENTS CHARACTERISTICS
- •Performance Status
- •Life Expectancy
- •Life expectancy of less than 6 months, as assessed by the principal investigator
- •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
- •Must be able to understand and sign informed consent
- •Female and male patients must agree to use an approved method of contraception during the study
排除标准
- •History of 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
- •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.
- •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
- •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 > 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: Patient 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 < 3 months 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.
结局指标
主要结局
Estimate the maximum dose that can be safely administered to a patient; Characterize the toxicity profile of CAT-8015; Study the clinical pharmacology of CAT-8015; Observe anti-tumor activity, if any.
次要结局
- To assess the immunogenic potential of CAT-8015 to induce antibodies; To investigate the potential of biomarkers to predict any therapeutic or toxic response.
研究者
研究点 (3)
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