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临床试验/NCT00003110
NCT00003110已完成2 期

A Phase II Trial of 72-Hour Continuous Infusion Bleomycin as Salvage Therapy in AIDS-Related and Immunocompetent Non-Hodgkin's Lymphoma

Case Comprehensive Cancer Center2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 1997年7月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
5
试验地点
2
主要终点
The effectiveness of bleomycin in treating patients with non-Hodgkin's lymphoma.

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bleomycin in treating patients with non-Hodgkin's lymphoma.

详细描述

OBJECTIVES: I. Determine the objective response rate, response duration and survival of patients receiving bleomycin as salvage therapy for AIDS-related or immunocompetent non-Hodgkin's lymphoma. II. Assess the feasibility and toxicity of treatment for this disease. III. Evaluate the quality of life of AIDS and non-AIDS patients with non-Hodgkin's lymphoma.

OUTLINE: Patients are stratified by number of prior cytotoxic chemotherapy regimens, prior radiotherapy, and HIV/AIDS status. Patients receive bleomycin by continuous infusion for 72 hours every 3 weeks. Induction therapy consists of 3 cycles. Patients who achieve complete remission receive 2 more cycles. Patients with partial remission or stable disease may continue therapy until disease progression or unacceptable toxicity occurs. Quality of life assessments are conducted at beginning of therapy, every 3 weeks, and at completion of treatment. Patients are followed every 3 months for overall survival.

PROJECTED ACCRUAL: A total of 32 patients will be accrued.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The effectiveness of bleomycin in treating patients with non-Hodgkin's lymphoma.

时间窗: Continuous infusion for 72 hours every 3 weeks. Induction therapy consists of 3 cycles. Patients who achieve CR receive 2 more cycles. Patients with PR or stable disease may continue therapy until disease progression or unacceptable toxicity occurs.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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