NCT00293488已完成1 期
An Open Label Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of SL-11047 in Patients With Refractory Lymphoma
Progen Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as SL-11047, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of SL-11047 in treating patients with relapsed or refractory lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of SL-11047 in patients with relapsed or refractory lymphoma.
- Describe and quantify the toxicity of SL-11047 administered to patients with relapsed or refractory lymphoma.
Secondary
- Describe the pharmacokinetics of SL-11047 administered as a 30-minute IV infusion.
- Assess the response rate and duration of response in patients treated with SL-11047.
- Assess the level of SL-11047 within tumor tissues following intravenous administration of the drug.
- Determine the sensitivity of abnormal circulating macrophages to SL-11047.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically* confirmed Hodgkin's or non-Hodgkin's lymphoma (NHL) of any histology
- •The following NHL types are eligible:
- •Diffuse large B-cell lymphoma
- •Follicular lymphoma
- •Mantle Cell lymphoma
- •Marginal zone lymphoma (including lymphoma of mucosa-associated tissue [MALT])
- •Anaplastic large cell lymphoma
- •Peripheral T-cell lymphoma
- •Cutaneous T-cell lymphoma
- •T/NK cell lymphoma
- •Angioimmunoblastic lymphadenopathy-type T-cell lymphoma
- •Burkitt's lymphoma NOTE: * If histologic confirmation was made at initial diagnosis, confirmation of relapsed or refractory disease can be made by repeat histologic evaluation OR by evidence of regrowth at a site of disease that was previously histologically confirmed
- •Relapsed after or refractory to ≥ 2 prior therapeutic regimens OR patient is ineligible to receive potentially curative therapy
- •Bidimensionally measurable or evaluable (e.g., bone marrow or infiltrative organ involvement) disease by physical exam or radiographic study
- •No suspicion or evidence of lymphomatous meningitis
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 12 weeks
- •ECOG performance status 0-4
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use medically prescribed contraception
- •Absolute neutrophil count ≥ 1,000/mm^3*
- •Platelet count ≥ 50,000/mm^3*
- •Hemoglobin ≥ 8 g/dL*
- •Serum creatinine ≤ 2.0 mg/dL
- •Total bilirubin ≤ 2.0 mg/dL**
- •Transaminases < 5 times upper limit of normal**
- •No other malignancy within the past 5 years other than curatively treated non-metastatic skin cancer or in situ cervical carcinoma
- •No history of significant or symptomatic cardiac arrhythmia
- •No history of myocardial infarction
- •No significant ventricular conduction abnormality by ECG or Holter monitoring, as evidenced by any of the following:
- •Prior myocardial infarction
- •Three or more premature ventricular contractions in a row
- •No history of pancreatitis
- •No history of recent gastrointestinal bleeding
- •Must have heme-negative stool at enrollment NOTE: *Cytopenias due to direct lymphomatous involvement allowed
- •NOTE: **Elevated due to direct lymphomatous involvement allowed
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 3 weeks since prior chemotherapy
- •Recovered from prior chemotherapy (alopecia or anemia allowed)
- •More than 3 weeks since prior investigational drugs
- •No prophylactic antiemetics during course 1
- •No other concurrent investigational drugs
排除标准
- 未提供
研究者
研究点 (2)
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