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Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma

2019年12月11日 更新者：University of Wisconsin, Madison

A Phase II Study of Velcade and Temsirolimus for Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

The investigators want to find out if the drugs Velcade and temsirolimus given together are effective in treating cancer. Velcade and temsirolimus are each FDA approved individually for certain types of cancer (Velcade for multiple myeloma and mantle cell lymphoma, and temsirolimus for renal cell carcinoma) but are not currently approved in combination for B-cell non-Hodgkin lymphoma. The investigators are trying to find out if giving these 2 drugs together will improve the period of time that the patient's cancer is stopped or slowed from growing and causing symptoms.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

40

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
    • South Dakota
      • Rapid City、South Dakota、美国、57701
        • Rapid City Regional Hospital John T. Vucurevich Cancer Care Institute
    • Wisconsin
      • Green Bay、Wisconsin、美国、54143
        • Aurora Baycare Medical Center-GreenBay
      • Green Bay、Wisconsin、美国、54301
        • St Vincent Regional Cancer Center CCOP
      • Green Bay、Wisconsin、美国、54313
        • Bellin Memorial Hospital, Inc
      • La Crosse、Wisconsin、美国、54601
        • Gunderson Lutheran Health System
      • Madison、Wisconsin、美国、53715
        • UW Health Oncology- 1 S Park
      • Madison、Wisconsin、美国、53792
        • University of Wisconsin Cancer Center
      • Marinette、Wisconsin、美国
        • Aurora BayCare Medical Center
      • Marshfield、Wisconsin、美国、54449
        • Marshfield Clinic
      • Milwaukee、Wisconsin、美国、53226
        • Medical College of Wisconsin
      • Milwaukee、Wisconsin、美国、53211
        • Columbia St Mary's, Inc
      • Sheboygan、Wisconsin、美国、53081
        • Aurora Sheboygan Memorial Medical Center
      • Summit、Wisconsin、美国、53066
        • Aurora Medical Center in Summit
      • Two Rivers、Wisconsin、美国、54241
        • Aurora Medical Center in Two Rivers
      • Waukesha、Wisconsin、美国、53188
        • Waukesha Memorial Hospital
      • Wausau、Wisconsin、美国、54401
        • Aspirus Wausau Hospital
      • Wauwatosa、Wisconsin、美国、53226
        • Aurora Health Care Metro, Inc.
      • Wisconsin Rapids、Wisconsin、美国、54494
        • UW Cancer Center-Riverview

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 及以上 (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

Inclusion Criteria:

  • Relapsed or refractory B-cell non-Hodgkin lymphoma which includes: diffuse large B-cell lymphoma; primary mediastinal large B-cell lymphoma; follicular lymphoma (grade 1, 2 or 3); mantle cell lymphoma; small lymphocytic lymphoma; marginal zone lymphoma; lymphoplasmacytic lymphoma; B-cell lymphoblastic lymphoma; or Burkitt lymphoma. "Grey-zone" lymphomas must be approved by the Wisconsin Oncology Network (WON) Study Chair or Principal Investigator prior to enrollment.
  • At least one measurable tumor mass (>1.5 cm in the long axis and > 1.0 cm in the short axis) that has not been previously irradiated, or has grown since previous irradiation.
  • Documented relapse or progression following prior antineoplastic therapy.
  • No clinical or documented radiographic evidence of central nervous system lymphoma.
  • Eastern Cooperative Oncology Group [ECOG] performance status of 0-2.
  • The following clinical laboratory values within 14 days prior to enrollment:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109 cells / L
  • Platelets ≥ 100 x 109 cells / L
  • Alanine transaminase (ALT) and Aspartate transaminase (AST) ≤ 3X the upper limit of normal (ULN)
  • Total bilirubin ≤ 2X the upper limit of normal (ULN).
  • Calculated creatinine clearance ≥40 mL/min (using the Cockcroft-Gault equation).
  • Female subjects must be either post-menopausal for at least 1 year or surgically sterilized, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of Velcade, or agree to completely abstain from heterosexual intercourse.
  • Male subjects, even if surgically sterilized (ie, status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.

Exclusions:

  • Antineoplastic, experimental, or radiation therapy within 14 days prior to enrollment, or 21 days prior to Day 1 of Cycle 1.
  • Radioimmunoconjugates within 10 weeks of Day 1 of Cycle 1.
  • Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or any prior history of allogeneic stem cell transplant.
  • Platelet transfusion within 7 days of Day 1 of Cycle 1.
  • Ongoing therapy with glucocorticoids. Prednisone ≤15 mg per day or its equivalent is allowed.
  • Patient has Grade 2 or greater peripheral neuropathy within 14 days before enrollment.
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • Patient has hypersensitivity to Velcade, boron or mannitol.
  • Female subjects that are pregnant or breast-feeding.
  • Serious medical or psychiatric illness that is likely to interfere with participation
  • Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
  • Prior therapy with both Velcade and temsirolimus. Patients who have previously been treated with either Velcade or temsirolimus (but not both) are eligible.
  • Radiation therapy within 3 weeks before randomization.
  • Patients must not be taking the following strong CyP3A inducers at study entry: phenytoin, phenobarbital, rifampin, carbamazepin, rifabutin, rifampicin, a one week washout period is required.

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：Velcade plus Temsirolimus

Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)

Treat for up to 6 cycles, cycles are 35 days long.
药品：Velcade
Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
其他名称：
  • bortezomib, PS-341
药品：Temsirolimus
Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
其他名称：
  • 托利塞尔

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
Overall Response Rate
大体时间：Up to 60 months
The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by overall response rate (ORR) to therapy. ORR is the sum of patients with a Complete Response and Partial Response to therapy. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete REsponse (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Up to 60 months
Progression Free Survival
大体时间：Up to 60 months
The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by progression-free survival (PFS).
Up to 60 months

次要结果测量

结果测量
措施说明
大体时间
Safety of This Regimen
大体时间：Up to 36 months
Safety of the regimen will be measured by frequency and severity of adverse events.
Up to 36 months
Complete Response Rate
大体时间：Up to 60 months
The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.
Up to 60 months
Tolerability of the Regimen
大体时间：Up to 36 months
Tolerability of the regimen is measured by the number of subjects able to complete the therapy as planned.
Up to 36 months
Duration of Response
大体时间：Up to 60 months
Duration of Response is how long a response to therapy is held before a subject has progressive disease.
Up to 60 months
Overall Survival
大体时间：Up to 60 months
Length of time from enrollment until death.
Up to 60 months

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 Wisconsin, Madison

合作者

National Cancer Institute (NCI)
Pfizer
Millennium Pharmaceuticals, Inc.

调查人员

  • 首席研究员：Brad S Kahl, MD、Universtity of Wisconsin- Madison
  • 学习椅：Timothy S Fenske, MD、Medical College of Wisconsin

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

2011年2月1日

初级完成 (实际的)

2013年10月1日

研究完成 (实际的)

2014年6月1日

研究注册日期

首次提交

2011年1月20日

首先提交符合 QC 标准的

2011年1月21日

首次发布 (估计)

2011年1月24日

研究记录更新

最后更新发布 (实际的)

2019年12月13日

上次提交的符合 QC 标准的更新

2019年12月11日

最后验证

2017年7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

  • HO10407
  • A534260 (其他标识符：UW Madison)
  • SMPH\MEDICINE\HEM-ONC (其他标识符：UW Madison)
  • H-2010-0393 (其他标识符：IRB)
  • NCI-2011-00647 (注册表标识符：NCI Trial ID)

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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