Vorinostat and Rituximab in Treating Patients With Indolent Non-Hodgkin Lymphoma
A Phase II Study of Vorinostat (Suberoylanilide Hydroxamic Acid) Plus Rituximab in Indolent Non-Hodgkin's Lymphoma
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving vorinostat together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving vorinostat together with rituximab and to see how well it works in treating patients with indolent non-Hodgkin lymphoma.
研究概览
详细说明
OBJECTIVES:
- To evaluate the anti-tumor activity of vorinostat and rituximab, in terms of objective response rate, time to progression, and survival, in patients with indolent non-Hodgkin lymphoma.
- To assess the toxicity profile of this regimen in these patients.
OUTLINE: Patients receive oral vorinostat twice daily on days 1-14 and rituximab IV on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
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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California
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Beverly Hills、California、美国、90211
- Tower Cancer Research Foundation
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Duarte、California、美国、91010-3000
- City of Hope Comprehensive Cancer Center
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Pasadena、California、美国、91105
- City of Hope Medical 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
Inclusion Criteria:
Patients must have histologically or cytologically confirmed indolent Non-Hodgkin's Lymphoma; included in this category are newly diagnosed or relapsed/refractory follicular center lymphomas grade I, II, III, relapsed/refractory marginal zone B-cell lymphoma (nodal and extranodal), relapsed/refractory mantle cell lymphoma
Patients must have measurable disease by computed tomography (CT) scan; positron emission tomography (PET) scan evaluations are desirable but not mandatory, so that patients with negative PET scans but measurable disease by CT are eligible
Patients may have had up to four prior chemotherapeutic regimens; steroids alone and local radiation do not count as regimens (radiotherapy must have been completed at least 14 days prior to starting vorinostat); Rituxan alone does not count as a regimen; however, Bexxar or Zevalin do; for treated patients, the most recent therapy must have failed to induce a complete response (i.e., there is persistent disease by CT or PET), or there must be disease progression or recurrence after the most recent therapy
Patients may be enrolled who relapse after autologous stem cell transplant if they are at least three months after transplant, and after allogeneic transplant if they are at least six month post transplant; to be eligible after either type of transplant, patients should have no active related infections (i.e., fungal or viral); in the case of allogeneic transplant relapse, there should be no active acute graft versus host disease (GvHD) of any grade, and no chronic graft versus host disease other than mild skin, oral, or ocular GvHD not requiring systemic immunosuppression
Life expectancy of greater than 3 months
Eastern Cooperative Oncology Group (ECOG) performance status 2 (Karnofsky >= 60%)
Absolute neutrophil count >= 1,000/mcL
Platelets >= 100,000/mcL
Total bilirubin within normal institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
Creatinine up to and including 2 mg/dl
Pre-menopausal women must have a negative serum pregnancy test prior to entry on this study; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
Patients who have had chemotherapy within 4 weeks, or radiotherapy within 2 weeks or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded; this does not include use of steroids, which may continue until two days prior to enrollment; low dose chlorambucil should be stopped two weeks prior to beginning vorinostat; valproic acid should be stopped at least two weeks prior to enrollment; nitrosoureas and mitomycin should be stopped 6 weeks prior to enrollment
Patients may not be receiving any other investigational agents
Patients with known brain metastases are excluded from this clinical trial unless the metastases are controlled after therapy and have not been treated with steroids within the past two months
History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat
There must be no plans for the patient to receive concurrent hormonal, biological, or radiation therapy
Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study; breastfeeding should be discontinued if mother is treated with vorinostat
Human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy are ineligible; in addition, HIV patients not receiving combination antiretroviral therapy are also ineligible
Patients with other active malignancies are ineligible for this study
Patients with preexisting or previous coagulation issues are not excluded from study as long as 1) previous pulmonary embolism or deep vein thrombosis have been adequately treated or 2) if they are actively receiving Coumadin or lovenox for anticoagulation; patients who are already on coumadin or lovenox do not need to take additional 40 mg subcutaneous injections daily
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 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:Vorinostat and Rituximab
Vorinostat by mouth two times (2X) per day for two weeks followed by one week of rest.
Rituximab intravenously once every three weeks .
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Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.
200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle.
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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 |
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Overall Response Rate (Complete and Partial Response)
大体时间:After every 3 cycles, up to 1 year after the start of treatment
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Response was assessed according to the 2007 Cheson criteria using CT scans or PET: Complete Response (CR), Disappearance of all evidence of disease; Partial Response (PR), >=50% decrease in the Sum of the Product of Diameters (SPD) of up to 6 largest dominant masses and no increase in the size of other nodes; Overall Response (OR) = CR + PR.
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After every 3 cycles, up to 1 year after the start of treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Progression-free Survival
大体时间:Until disease progress\relapse, up to 1 year after the start of treatment
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Progression\Relapse is defined using the 2007 Cheson criteria, as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy; or at least a 50% increase for nadir in the SPD of any previously involved nodes; or at least a 50% increase in the longest diameter of any singe previously identified node more than 1 cm in its short axis.
Estimated using the product-limit method of Kaplan and Meier.
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Until disease progress\relapse, up to 1 year after the start of treatment
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Number of Participants With Grade 3 and 4 Toxicities
大体时间:3 weeks after the stop of treatment
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Grade 3 & 4 toxicities at least possible related to study drugs during any cycle of treatment.
Toxicity graded according to Common Terminology Criteria for Adverse Events version 3.0.
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3 weeks after the stop of treatment
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合作者和调查者
调查人员
- 首席研究员:Robert Chen, MD、City of Hope Medical Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
- IV期3级滤泡性淋巴瘤
- 复发性 3 级滤泡性淋巴瘤
- III 期 1 级滤泡性淋巴瘤
- III期2级滤泡性淋巴瘤
- III期3级滤泡性淋巴瘤
- IV 期 1 级滤泡性淋巴瘤
- IV 期 2 级滤泡性淋巴瘤
- III期套细胞淋巴瘤
- IV期套细胞淋巴瘤
- I 期 1 级滤泡性淋巴瘤
- I 期 2 级滤泡性淋巴瘤
- 复发性 1 级滤泡性淋巴瘤
- 复发性 2 级滤泡性淋巴瘤
- 连续 II 期 1 级滤泡性淋巴瘤
- 连续 II 期 2 级滤泡性淋巴瘤
- 非连续性 II 期 1 级滤泡性淋巴瘤
- 非连续性 II 期 2 级滤泡性淋巴瘤
- 非连续性 II 期边缘区淋巴瘤
- 复发性边缘区淋巴瘤
- I期边缘区淋巴瘤
- III期边缘区淋巴瘤
- IV期边缘区淋巴瘤
- 连续II期边缘区淋巴瘤
- 黏膜相关淋巴组织结外边缘区B细胞淋巴瘤
- 淋巴结边缘区B细胞淋巴瘤
- 脾边缘区淋巴瘤
- 复发性套细胞淋巴瘤
- 连续II期套细胞淋巴瘤
- 非连续性 II 期套细胞淋巴瘤
- 非连续性 II 期 3 级滤泡性淋巴瘤
- I期套细胞淋巴瘤
- 连续 II 期 3 级滤泡性淋巴瘤
- I期3级滤泡性淋巴瘤
其他相关的 MeSH 术语
其他研究编号
- 07195
- P30CA033572 (美国 NIH 拨款/合同)
- CDR0000600989 (注册表标识符:PDQ)
- NCI-2010-00531 (注册表标识符:NCI CTRP)
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