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Bortezomib and Gemcitabine Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

2016年3月30日 更新者：Jonathan Friedberg、University of Rochester

Phase II Pilot Study of Bortezomib (VELCADE®) and Gemcitabine for Patients With Relapsed or Refractory Hodgkin's Lymphoma

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine hydrochloride may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine hydrochloride works in treating patients with relapsed or refractory Hodgkin's lymphoma.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

Primary

  • Determine the overall response rate (partial and complete response) in patients with relapsed or refractory Hodgkin's lymphoma treated with bortezomib and gemcitabine hydrochloride.

Secondary

  • Determine the safety and toxic effects of this regimen in these patients.
  • Determine the time to progression in patients treated with this regimen.
  • Correlate NF-kB inhibition and proteasome activity with response in patients treated with this regimen.

OUTLINE: This is a multicenter, pilot study.

Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

研究类型

介入性

注册 (实际的)

18

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
    • New York
      • Rochester、New York、美国、14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 120年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically confirmed Hodgkin's lymphoma

    • Recurrent or refractory disease after prior standard combination chemotherapy
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 1 cm by physical exam or imaging studies
  • No history of non-Hodgkin's lymphoma
  • No history of other hematological malignancy

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count ≥ 1,000/mm^3

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert's disease or involvement by Hodgkin's lymphoma)
  • AST ≤ 3 times ULN (unless due to involvement by Hodgkin's lymphoma)

Renal

  • Creatinine clearance ≥ 30 mL/min

Cardiovascular

  • Ejection fraction ≥ 40% by MUGA or echocardiogram (in patients with a history of cardiac disease)

Pulmonary

  • Must not require supplemental oxygen therapy

Immunologic

  • No known HIV infection
  • No uncontrolled bacterial, viral, or fungal infection

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy requiring therapy
  • No peripheral neuropathy ≥ grade 2 within the past 14 days
  • No hypersensitivity to boron
  • No hypersensitivity to mannitol

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 30 days since prior monoclonal antibody therapy for Hodgkin's lymphoma
  • More than 6 months since prior autologous stem cell transplantation
  • No prior allogeneic stem cell transplantation
  • No concurrent sargramostim (GM-CSF)
  • No concurrent pegfilgrastim or filgrastim (G-CSF)
  • No concurrent interleukin-11(oprelvekin)

Chemotherapy

  • See Disease Characteristics
  • More than 30 days since prior chemotherapy for Hodgkin's lymphoma
  • No prior treatment with gemcitabine hydrochloride

Endocrine therapy

  • More than 30 days since prior corticosteroid therapy for Hodgkin's lymphoma
  • No concurrent corticosteroid therapy

Radiotherapy

  • More than 30 days since prior radiotherapy for Hodgkin's lymphoma

Other

  • No prior treatment with bortezomib
  • More than 14 days since prior investigational drugs
  • No other concurrent investigational agents

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

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
实验性的：Bortezomib, Gemcitabine Hdrochloride
药品：盐酸吉西他滨
药品：硼替佐米

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
Response Rate After 2 Courses of Therapy
大体时间：21 Days/course for up to 2 courses
Response was evaluated after two cycles of therapy using the 1999 Cheson response criteria. All responses were based on CT scans. The criteria that were developed include anatomic definitions of response, with normal lymph node size after treatment of 1.5 cm in the longest transverse diameter by computer-assisted tomography scan. A designation of complete response/unconfirmed was adopted to include patients with a greater than 75% reduction in tumor size after therapy but with a residual mass, to include patients-especially those with large-cell NHL-who may not have residual disease. For patients who had FDG-PET imaging, metabolic response was defined as a decrease in the standardized uptake value in target lesions (regions of abnormal FDG uptake on pretreatment FDG-PET images) to below three on posttreatment FDG-PET imaging). All PET scans were reviewed and interpreted by a single radiologist (SV).
21 Days/course for up to 2 courses

次要结果测量

结果测量
措施说明
大体时间
Change in Proteasome Activity Compared to Baseline (Cycle 1)
大体时间：baseline to 2 hours
Peripheral blood (40 ml) was collected on cycle 1, day 1 of prebortezomib at baseline and 2 hrs post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.
baseline to 2 hours
Change in Proteasome Activity Compared to Baseline (Cycle 2)
大体时间：baseline and 1-2 weeks after cycle 2, day 11
Peripheral blood (40 ml) was collected at baseline and 1-2 weeks after cycle 2, day 11 post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.
baseline and 1-2 weeks after cycle 2, day 11

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Rochester

调查人员

  • 首席研究员：Jonathan W. Friedberg, MD、James P. Wilmot Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年4月1日

初级完成 (实际的)

2008年5月1日

研究注册日期

首次提交

2005年12月6日

首先提交符合 QC 标准的

2005年12月6日

首次发布 (估计)

2005年12月7日

研究记录更新

最后更新发布 (估计)

2016年5月9日

上次提交的符合 QC 标准的更新

2016年3月30日

最后验证

2016年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CDR0000448635
  • URCC-U9404
  • URCC-RSRB-10368
  • MILLENNIUM-VEL-03-079
  • LILLY-B9E-US-X433
  • DFCI-04388

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.

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条件

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