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临床试验/NCT00006220
NCT00006220终止1 期

Arsenic Trioxide Alone or With ATRA (Vesanoid) for Resistant Hematologic Malignancy

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 1999年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
5
试验地点
1
主要终点
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT)

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Tretinoin may help hematologic cancer cells develop into normal white blood cells.

PURPOSE: Phase I/II trial to study the effectiveness of arsenic trioxide with or without tretinoin in treating patients who have hematologic cancer that has not responded to previous therapy.

详细描述

This is a dose escalation and efficacy study of arsenic trioxide. In the efficacy study, patients are stratified according to diagnosis (acute myelogenous leukemia vs acute lymphocytic leukemia vs myelodysplastic syndrome vs multiple myeloma vs non-Hodgkin's lymphoma and Hodgkin's disease). Phase I: Patients receive arsenic trioxide IV over 2 hours daily for 28 days. Treatment repeats every 42-59 days in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) or partial remission (PR) receive up to 4 courses. Patients who fail to achieve CR or PR or who experience disease progression may receive arsenic trioxide and tretinoin daily for 28 days every 42-59 days for up to 7 courses. Patients who fail to achieve CR or PR or experience disease progression with arsenic trioxide and tretinoin are removed from study. Cohorts of 3-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Phase II: Patients receive the MTD of arsenic trioxide as in phase I for up to 7 courses. Patients who fail to achieve CR or PR after 3 courses or experience disease progression are either taken off study or treated with arsenic trioxide and tretinoin as in phase I. Patients are followed monthly for 6 months, and then every 3 months for 18 months.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Phase I

Experimental

Starting dose of arsenic trioxide of 0.15 mg/kg/day

干预措施: arsenic trioxide (Drug)

Phase II

Experimental

MTD of arsenic trioxide

干预措施: arsenic trioxide (Drug)

Treatment Failure

Experimental

Arsenic trioxide and tretinoin

干预措施: arsenic trioxide (Drug)

Treatment Failure

Experimental

Arsenic trioxide and tretinoin

干预措施: tretinoin (Drug)

结局指标

主要结局

Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT)

时间窗: 28 days

Likelihood of complete (CR) or partial (PR) response following therapy

时间窗: 6 months

次要结局

  • Explore the pharmacokinetics of arsenic trioxide alone and in combination with ATRA
  • Evaluate acute and chronic toxicities of arsenic trioxide alone and in combination with ATRA.
  • Determine the effects of arsenic trioxide alone and combined with ATRA on bcl-2, pml, and class I antigen expression and on apoptosis. Determine the effects of arsenic trioxide on T and B cell number and function

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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