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Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma

2013年2月8日 更新者:National Cancer Institute (NCI)

PHASE II STUDY OF 9-AMINOCAMPTOTHECIN (9-AC/DMA, NSC# 603071) IN PREVIOUSLY TREATED HODGKIN'S DISEASE AND NON-HODGKIN'S LYMPHOMA: IWF GRADES A-H

Phase II trial to study the effectiveness of aminocamptothecin in treating patients who have refractory or recurrent Hodgkin's disease or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

研究概览

地位

完全的

条件

详细说明

OBJECTIVES:

I. Evaluate the response rate and duration of response to aminocamptothecin (9-AC) in patients with refractory or relapsed Hodgkin's disease or non-Hodgkin's lymphoma.

II. Assess the toxicity of 9-AC in these patients. III. Validate a preliminary pharmacodynamic model relating total 9-AC concentration, albumin, and bilirubin to toxicity.

IV. Determine whether 9-AC concentrations correlate with response.

OUTLINE: Patients are stratified by disease histology (International Working Formulation (IWF) A-C vs IWF D-F) and center.

Patients receive aminocamptothecin IV continuously on days 1-3. Treatment repeats every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease, partial response (PR), or complete response (CR) may receive 2 additional courses past best response (minimum of 6 courses if PR or CR). Patients are followed every 6 months for 2 years, and then annually thereafter.

研究类型

介入性

注册 (实际的)

37

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

    • District of Columbia
      • Washington、District of Columbia、美国、20307-5000
        • Walter Reed Army Medical Center
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • University of Minnesota Cancer Center
    • Missouri
      • Saint Louis、Missouri、美国、63110
        • Washington University Barnard Cancer Center
    • New Jersey
      • Camden、New Jersey、美国、08103
        • Cooper Cancer Institute
      • Paterson、New Jersey、美国、07503
        • St. Joseph's Hospital and 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 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically documented Hodgkin's disease (closed to accrual 4/15/2000) OR
  • Histologically documented non-Hodgkin's lymphoma (NHL) of one of the following International Working Formulation (IWF) histologies:

    • Small lymphocytic (absolute lymphocyte count less than 5,000)
    • IWF A Follicular, predominantly small cleaved cell
    • IWF B Follicular mixed
    • IWF C Follicular large cell
    • IWF D* Diffuse small cleaved cell
    • IWF E* Diffuse mixed
    • IWF F* Diffuse large cell
    • IWF G* Large cell, immunoblastic
    • IWF H* * Accrual of patients with these diagnoses closed 4/15/2000
  • Pathology review required within 60 days of registration
  • Refractory to or relapsed after prior chemotherapy as follows:

    • Low-grade NHL (IWF A-C): 1 or 2 prior therapies
    • Intermediate-grade NHL (IWF D-H): 1 prior therapy (stratum closed 4/15/2000)
    • Hodgkin's disease: 1 or 2 prior therapies (stratum closed 4/15/2000)
  • Treatment with the same drugs on 2 different schedules considered 1 therapy
  • Measurable disease by physical exam or imaging studies
  • Mass larger than 1 x 1 cm
  • Documented progression required of previously irradiated lesions
  • The following are not considered measurable:

    • Ascites or pleural effusion
    • Bone marrow involvement
    • Positive barium studies
    • Bony disease (lytic lesions noted)
    • No mantle cell or transformed lymphoma
    • No parenchymal or leptomeningeal CNS disease
  • A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

  • Age: 18 and over
  • Performance status: CALGB 0-2
  • Unless hypersplenism or biopsy-proven bone marrow involvement:

    • Absolute granulocyte count at least 1,500/mm3
    • Platelet count at least 100,000/mm3
  • Bilirubin normal
  • AST no greater than 4 times normal
  • Creatinine normal
  • No suspected HIV infection
  • No second malignancy within past 5 years except:

    • Curatively treated carcinoma of the cervix
    • Curatively treated basal cell skin cancer
    • No uncontrolled infection or other serious medical condition
    • No psychiatric condition that precludes informed consent
    • Not pregnant or nursing
    • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No prior allogeneic or autologous bone marrow transplant
  • More than 3 weeks since chemotherapy (6 weeks since nitrosoureas, melphalan, or mitomycin)
  • No prior camptothecin
  • More than 3 weeks since radiotherapy

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:aminocamptothecin
850 micrograms/square meter/day (total dose 2550 micrograms/square meter) via central venous catheter using infusion pump over 72 hours + one cycle Cycle repeated every 14 days for minimum of 6 cycles if partial or complete response

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Response
大体时间:2 years post treatment
2 years post treatment

次要结果测量

结果测量
大体时间
Toxicity
大体时间:day 1 of each cycle
day 1 of each cycle
9-AC/DMA concentrations
大体时间:Pre-treatment cycle 1 and just prior to completion of cycle 1
Pre-treatment cycle 1 and just prior to completion of cycle 1

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。

调查人员

  • 学习椅:Nancy L. Bartlett, MD、Washington University Siteman 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。

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

1996年4月1日

初级完成 (实际的)

2003年4月1日

研究完成 (实际的)

2008年1月1日

研究注册日期

首次提交

1999年11月1日

首先提交符合 QC 标准的

2004年4月21日

首次发布 (估计)

2004年4月22日

研究记录更新

最后更新发布 (估计)

2013年2月11日

上次提交的符合 QC 标准的更新

2013年2月8日

最后验证

2013年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • NCI-2012-02791
  • U10CA031946 (美国 NIH 拨款/合同)
  • CLB-9551
  • CDR0000064666 (注册表标识符:PDQ (Physician Data Query))

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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