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Arsenic Trioxide, Thalidomide, Dexamethasone, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma

2012年5月24日 更新者:OHSU Knight Cancer Institute

A Phase II Study of Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, dexamethasone, and ascorbic acid, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Sometimes when chemotherapy is given, it does not stop the growth of cancer cells. The cancer is said to be resistant to chemotherapy. Giving arsenic trioxide together with chemotherapy may reduce drug resistance and allow the cancer cells to be killed. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.

研究概览

详细说明

OBJECTIVES:

  • Determine the safety and side effects of arsenic trioxide administered in combination with thalidomide, dexamethasone, and ascorbic acid in patients with relapsed or refractory multiple myeloma.
  • Determine, preliminarily, the anticancer effects of this regimen in these patients.
  • Determine the duration of anticancer effects in patients treated with this regimen.
  • Determine the effect of this regimen on bone and immune function in these patients.

OUTLINE: Patients receive arsenic trioxide IV continuously and oral ascorbic acid once daily on days 1-5 in week 1 and twice weekly in weeks 2-12 and oral thalidomide once daily in weeks 1-14. Treatment with arsenic trioxide, ascorbic acid, and thalidomide repeats every 14 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone once daily on days 1-4. Treatment with dexamethasone repeats every 28 days.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

研究类型

介入性

注册 (实际的)

2

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

    • Oregon
      • Portland、Oregon、美国、97239-3098
        • OHSU Knight Cancer Institute

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

16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:

  • Diagnosis of multiple myeloma (MM)

    • Relapsed or refractory disease
  • Monoclonal immunoglobulin spike by serum electrophoresis of ≥ 1 gm/dL AND/OR urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours
  • Has received ≥ 2 prior treatment regimens for MM
  • None of the following are allowed:

    • Non-secretory MM
    • Plasma cell leukemia
    • Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • Platelet count ≥ 50,000/mm^3 (30,000/mm^3 if the bone marrow is extensively infiltrated)
  • Hemoglobin ≥ 8.0 g/dL
  • Absolute neutrophil count ≥ 1,000/mm^3

Hepatic

  • AST and ALT < 3.0 times upper limit of normal (ULN)
  • Bilirubin < 2.0 times ULN

Renal

  • Not specified

Cardiovascular

  • No cardiac disease, including any of the following conditions:

    • History of recurrent supraventricular arrhythmia
    • History of sustained ventricular tachycardia
    • History of second or third degree AV block
    • History of left bundle branch block
    • Cardiomyopathy with LVEF < 40%
    • Uncontrolled ischemic heart disease
  • No myocardial infarction within the past 6 months
  • No prolonged QT interval > 500 ms

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • No HIV positivity
  • No neuropathy > grade 3
  • Potassium ≥ 4 mEq/L
  • Magnesium ≥ 1.8 mg/dL

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 30 days since prior investigational drugs

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:Arsenic Trioxide
Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid

研究衡量的是什么?

主要结果指标

结果测量
Response rate (complete response, partial response, and minimal response) as measured by bone marrow aspirate, biopsy, cytogenetic analysis, serum, urine, and immunofixation skeletal survey at 6 months and end of study treatment

次要结果测量

结果测量
Safety and tolerability as measured by physical exams, blood tests, and adverse events reports weekly

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

  • 首席研究员:Aleksandra Simic, MD、OHSU Knight Cancer Institute

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

2004年6月1日

初级完成 (实际的)

2006年2月1日

研究完成 (实际的)

2006年2月1日

研究注册日期

首次提交

2005年9月26日

首先提交符合 QC 标准的

2005年9月26日

首次发布 (估计)

2005年9月28日

研究记录更新

最后更新发布 (估计)

2012年5月28日

上次提交的符合 QC 标准的更新

2012年5月24日

最后验证

2010年6月1日

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.

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