NCT00040950已完成1 期
A Multi-Center, Phase I, Open Label, Two Arm, Non-Randomized, Dose-Escalation, Study Of The Safety And Tolerability Of CPG 7909 In Patients Receiving Rituxan For Relapsed Or Refractory B-Cell Non-Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Biological therapies such as CpG 7909 use different ways to stimulate the immune system and stop cancer cells from growing. Combining CpG 7909 with rituximab may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of CpG 7909 plus rituximab in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of subcutaneous and IV CpG 7909 when administered with rituximab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the disease response in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of CpG 7909. Patients are sequentially assigned to 1 of 2 treatment groups.
- Group A: Patients receive rituximab IV over 4-5 hours followed by CpG 7909 IV over 2 hours on day 1. Courses repeat weekly for 4 weeks.
- Group B: Patients receive rituximab as above followed by CpG 7909 subcutaneously on day 1. Courses repeat weekly for 4 weeks.
Cohorts of 3-6 patients receive escalating doses of CpG 7909 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
- 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 CD20+ B-cell non-Hodgkin's lymphoma (NHL)
- •CD20 positive by immunohistochemistry or flow cytometry
- •Relapsed or refractory disease
- •Bidimensionally measurable disease
- •Sole site of measurable disease within a previously irradiated field allowed provided there was disease progression at that site
- •No pre-existing ascites or pleural effusions
- •No known CNS involvement by NHL
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •Neutrophil count at least 1,000/mm3
- •Platelet count at least 50,000/mm3
- •Bilirubin less than 2 mg/dL
- •Transaminase less than 2 times upper limit of normal
- •No hepatitis B or C
- •Creatinine less than 2 mg/dL
- •Cardiovascular:
- •No significant cardiovascular disease
- •No New York Heart Association class III congestive heart failure
- •No myocardial infarction within the past 6 months
- •No unstable angina
- •No uncontrolled atrial or ventricular cardiac arrhythmias
- •No concurrent significant pulmonary disease
- •HIV negative
- •No acute infection requiring antibiotics
- •No fever over 38.2 degrees C within the past 3 days
- •No other malignancy within the past 5 years except basal cell or noninvasive squamous cell skin cancer or carcinoma in situ of the cervix
- •No pre-existing autoimmune disease or antibody-mediated disease, including:
- •Systemic lupus erythematosus
- •Rheumatoid arthritis
- •Multiple sclerosis
- •Sjogren's syndrome
- •Autoimmune thrombocytopenia
- •Controlled thyroid disease allowed
- •Concurrent autoantibodies without clinical autoimmune disease allowed
- •No history of allergic reactions attributed to compounds of similar composition to study drugs
- •No other medical history, including laboratory results, that would preclude study
- •No suspected or confirmed poor compliance or mental instability that would preclude study
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior allogeneic transplantation
- •More than 30 days since prior hematopoietic growth factors (e.g., filgrastim (G-CSF) or epoetin alfa)
- •More than 30 days since prior immunotherapy
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排除标准
- 未提供
研究者
研究点 (1)
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