临床试验/NCT00303966

NCT00303966终止2 期

A Phase II Study of BAY 43-9006 in Relapsed Chronic Lymphocytic Leukemia

National Cancer Institute (NCI)1 个研究点分布在 1 个国家目标入组 5 人开始时间: 2005年11月最近更新: 2014年5月7日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: National Cancer Institute (NCI)
入组人数: 5
试验地点: 1
主要终点: Objective Response Rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. This phase II trial is studying how well sorafenib works in treating patients with relapsed chronic lymphocytic leukemia.

详细描述

PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with recurrent chronic lymphocytic leukemia (CLL) treated with sorafenib.

II. Determine the toxicity in patients treated with sorafenib.

SECONDARY OBJECTIVES:

I. Correlate bone marrow angiogenesis, CLL tumor cell expression of vascular endothelial growth factor (VEGF), VEGF receptors (flt-1, KDR, flt-4 and neuropilin-1), basic fibroblast growth factor, and plasma interleukin-8 levels with response.

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

•Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) by NCI-WG immunophenotype and blood criteria
•Documentation of current or prior peripheral blood (PB) or bone marrow (BM) immunophenotype compatible with CLL
•Patients who currently do not have > 5,000/mm³ absolute lymphocytosis are eligible if they have previously met PB lymphocytosis criteria and have a current immunophenotype documenting monoclonal B lymphocytosis morphologically and immunophenotypically compatible with CLL
•Intermediate-risk (Rai stage I or II) or high-risk (Rai stage III or IV) disease, including any of the following:
•Rai stage I disease with lymphocytosis and enlarged nodes
•Rai stage II disease with lymphocytosis plus splenomegaly and/or hepatomegaly (nodes positive or negative)
•Rai stage III disease with lymphocytosis plus anemia
•Rai stage IV disease with lymphocytosis and thrombocytopenia
•Must require treatment with active disease, experiencing disease related symptoms, or having deterioration of blood counts, meeting ≥ 1 of the following criteria:
•Presence of ≥ 1 of the following disease-related symptoms:
•Weight loss > 10% within the past 6 months
•Extreme fatigue (i.e., ECOG performance status 2: cannot work or unable to perform usual activities)
•Fever > 100.5°F for 2 weeks without evidence of infection
•Night sweats without evidence of infection
•Evidence of progressive marrow failure, as manifested by worsening of anemia (hemoglobin < 10 g/dL), thrombocytopenia (platelet count < 100,000/mm³), and/or neutropenia (neutrophil count < 2,000/mm³)
•Massive (i.e., > 6 cm below left costal margin) or progressive splenomegaly or discomfort from splenomegaly
•Massive nodes or clusters (i.e., > 10 cm in longest diameter), progressive adenopathy, or discomfort from lymphadenopathy
•Deterioration of blood counts and/or progressive lymphocytosis, with an increase of ≥ 10% documented over a 2-month period OR an anticipated doubling time < 6 months
•Relapsed disease
•Must receive at least 1, but no more than 3, prior chemotherapy regimens with any cytotoxic agent or antibody therapy
•No fludarabine refractory disease
•Responded to prior fludarabine without relapse or disease progression for at least 6 months
•Patients with a history of Coombs-positive hemolytic anemia are eligible provided recovery from treatment of hemolysis and off steroids
•No stage 0 CLL
•No known CNS involvement
•Life expectancy > 6 months
•ECOG performance status 0-2 OR Karnofsky performance status 70-100%
•Absolute neutrophil count ≥ 1,000/mm³
•Platelets ≥ 30,000/mm³
•Bilirubin ≤ 2 mg/dL
•AST/ALT ≤ 2.5 times upper limit of normal (ULN)
•Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min (for patients with creatinine levels above normal)
•No currently active second malignancy
•Not pregnant or nursing
•Negative pregnancy test
•Fertile patient must use effective contraception prior to and during study participation
•No uncontrolled hypertension, defined as blood pressure (BP) > 150/100 mm Hg on 2 different measurements at least 1 day apart with either systolic or diastolic number meeting this definition
•Patients may later enter the study, if they have achieved stable BP (i.e., < 140/90 mm Hg) on a regimen of ≤ 2 drugs after 6-8 weeks of therapy
•No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib
•No uncontrolled intercurrent illness including, but not limited to, any of the following:
•Symptomatic congestive heart failure
•Unstable angina pectoris
•Cardiac arrhythmia
•Psychiatric illness or social situations that would limit compliance with the study requirements
•No active infection requiring systemic antibiotics
•No evidence of bleeding diathesis
•No evidence of bowel perforation or obstruction risk
•No swallowing dysfunction leading to difficulty taking the study drug
•See Disease Characteristics
•Recovered from prior therapy
另有 10 项未显示

排除标准

未提供

研究组 & 干预措施

Treatment (sorafenib tosylate)

Experimental

Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

干预措施: sorafenib tosylate (Drug)

结局指标

主要结局

Objective Response Rate

时间窗: Up to week 25

Objective response is defined as a complete (CR) or partial (PR) remission. Complete remission is defined as no evidence of chronic lymphocytic leukemia (CLL) in marrow with normal hematopoiesis and no palpable lymphadenopathy. Partial remission is defined as improvement in blood counts from baseline with \>50% reduction in lymph nodes on examination. These are definitions from the CLL International Working Group (IWG).

Time to Disease Progression

时间窗: Up to 5.5 years

Time to disease progression will be defined as the time from treatment start until disease progression and will be evaluated using the Kaplan-Meier estimator. Those who do not progress will be censored at the time that they were last known to be progression free.

Overall Survival

时间窗: Up to 5.5 years

Overall survival will be defined as time from the start of treatment until death from any cause and will be evaluated using the Kaplan-Meier estimator.

次要结局

Changes in Mean Microvessel Density From Baseline to Week 25(Baseline and week 25)
Changes in Vascular Endothelial Growth Factor (VEGF) From Baseline to Week 25(Baseline and week 25)
Changes in Plasma Level of Interleukin-8 (IL-8) From Baseline to Week 25(Baseline and week 25)

研究者

发起方

National Cancer Institute (NCI)

申办方类型

Nih

责任方

Sponsor

研究点 (1)

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