Sunitinib in Treating Patients With Relapsed or Refractory Diffuse or Mediastinal Large B-Cell Lymphoma
A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019), an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
研究概览
详细说明
PRIMARY OBJECTIVES:
I. Determine the response rate in patients with relapsed or refractory, diffuse or mediastinal, large B-cell lymphoma treated with sunitinib malate.
II. Determine the toxicity of this drug in these patients. III. Determine the effects of this drug on peripheral blood biomarkers, circulating endothelial cells, and their precursors in these patients.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Ontario
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Kingston、Ontario、加拿大、K7L 3N6
- National Cancer Institute of Canada Clinical Trials Group
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Criteria:
- Histologically confirmed diffuse or mediastinal large B-cell lymphoma*, meeting the following criteria: Advanced or metastatic disease, Incurable by standard therapies, Relapsed or refractory disease [Note: *Patients with diffuse large B-cell lymphoma whose disease has transformed from an earlier diagnosis of low grade lymphoma (i.e., an indolent histology) are eligible]
- Bidimensionally measurable disease** by CT scan, MRI, or physical exam, with >= 1 disease site meeting 1 of the following criteria: Lymph nodes >= 1.5 cm x 1.5 cm by spiral CT scan, Non-nodal regions >= 1 cm x 1 cm by MRI, CT scan, or physical exam [Note: **Bone lesions are not considered bidimensionally measurable disease]
- Received 1-2 prior chemotherapy regimens that included doxorubicin hydrochloride; Prior stem cell transplantation and high-dose chemotherapy is considered one regimen; One prior non-chemotherapy regimen in the form of radiation allowed; Measurable disease must be outside the previously irradiated area;
- No sole site of disease in a previously irradiated area unless progressive disease or new lesions are documented; Low-dose palliative radiotherapy may be allowed
- No known brain metastases
- Life expectancy >= 12 weeks
- ECOG performance status 0-1
- Absolute granulocyte count >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- AST and ALT =< 2.5 times upper limit of normal (ULN)
- Bilirubin normal
- Calcium =< 3 mmol/L
- Creatinine =< 1.25 times ULN OR creatinine clearance >= 60 mL/min
- LVEF normal by MUGA
- None of the following in the past 12 months: cardiac arrhythmia, cerebrovascular accident (CVA), coronary/peripheral artery bypass graft or stenting, myocardial infarction, stable or unstable angina, symptomatic congestive heart failure, transient ischemic attack, pulmonary embolism
- No uncontrolled hypertension (systolic blood pressure >= 140 mm Hg or diastolic blood pressure >= 90 mm Hg)
- No New York Heart Association (NYHA) class III or IV heart disease
- No QTc prolongation (QTc interval >= 500 msec) or other significant ECG abnormalities
- No other prior malignancies except nonmelanoma skin cancer, in situ cervical cancer, or other solid tumors curatively treated with no evidence of disease for >= 5 years
- No history of allergic reaction to compounds of similar chemical or biological composition to sunitinib malate
- No other serious illness or medical condition that would preclude study participation, including, but not limited to, the following:
active, uncontrolled infection, serious or nonhealing wound, ulcer, or bone fracture, history of significant neurologic or psychiatric disorder that would impair the ability to obtain consent or limit compliance
- Other medical condition that might be aggravated by treatment
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- No bowel obstruction
- No condition that would impair the ability to swallow and retain sunitinib malate tablets, including any of the following:
Gastrointestinal tract disease resulting in inability to take oral medication or a requirement for IV alimentation, Prior surgical procedures affecting absorption, Active peptic ulcer disease
- No pre-existing hypothyroidism unless euthyroid on medication
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- At least 28 days since prior chemotherapy
- At least 28 days since prior radiotherapy and recovered; radiotherapy must have involved < 30% of functioning bone marrow
- At least 28 days since prior major surgery and recovered
- At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following: rifampin, phenytoin, rifabutin, hypericum perforatum (St. John's wort), carbamazepine, efavirenz, phenobarbital, tipranavir,
- At least 7 days since prior and concurrent CYP3A4 inhibitors, including any of the following: azole antifungals (e.g., ketoconazole, itraconazole), verapamil, clarithromycin, HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, nelfinavir), erythromycin, delavirdine, diltiazem,
- No prior therapy with other antiangiogenic agents or multitargeted tyrosine kinase inhibitors, including any of the following:
bevacizumab, sorafenib tosylate, pazopanib, thalidomide, AZD2171 vandetanib, AMG 706, vatalanib, VEGF Trap
- No concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g., warfarin); Concurrent dosing of =< 2 mg of warfarin daily for prophylaxis of thrombosis is allowed; Concurrent low molecular weight heparin is allowed provided INR is =< 1.5
- No other concurrent anticancer treatments, including investigational agents
- No concurrent agents with proarrhythmic potential, including any of the following: terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, flecainide
- No concurrent combination antiretroviral therapy for HIV-positive patients
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Arm I
This is a non-randomized, open-label, multicenter study.
Patients receive sunitinib malate orally once daily on days 1-28.
Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
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口头给予
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Objective Tumor Response
大体时间:Up to 3 years
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It is defined as per the Report of the International workshop to standardize response criteria for non-Hodgkin's lymphoma and reviewed independently
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Up to 3 years
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合作者和调查者
调查人员
- 首席研究员:Rena Buckstein、Canadian Cancer Trials Group
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
苹果酸舒尼替尼的临床试验
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Sarcoma Alliance for Research through CollaborationDana-Farber Cancer Institute; Cogent Biosciences, Inc.; The Life Raft Group尚未招聘