Modulation of Death Effector Expression By Short-Term Exposure to Low-Dose Interferon
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Descriptive Data on Expression of Death Effectors in Context of Low-dose Interferon
研究概览
简要总结
RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth of urothelial cancer.
PURPOSE: This randomized phase I trial is studying how well low-dose interferon alfa works in treating patients with cancer of the urothelium.
详细描述
OBJECTIVES:
- Determine the modulation of apoptosis-related pathways in patients with cancer of the urothelium treated with short-term low-dose interferon alfa.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 4 treatment arms.
In all arms, treatment begins at the time of the pre-operative visit and continues until the time of cystoscopy.
- Arm I: Patients receive low-dose interferon alfa subcutaneously (SC) twice daily.
- Arm II: Patients receive interferon alfa as in arm I at a higher dose.
- Arm III: Patients receive interferon alfa SC once daily.
- Arm IV: Patients receive interferon alfa as in arm III at a higher dose. In all arms, treatment continues in the absence of unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- 否
入选标准
- •Patients must have histologically proven urothelial cancer, known or suspected (e.g. by outside evaluation) to be muscle-invasive, and be scheduled for cystoscopy and transurethral biopsy as part of their routine evaluation at M. D. Anderson.
- •Patients must understand the investigational nature of this study and provide written, informed consent.
排除标准
- •Patients who are pregnant or lactating are not eligible. Women of child-bearing potential must have a negative pregnancy test before starting therapy.
- •Patients with current symptoms suggestive of clinically significant affective disorder.
- •Patients taking more than physiologic replacement doses of corticosteroids are not eligible.
研究组 & 干预措施
Arm I
Low-dose interferon alfa subcutaneously (SC) twice daily.
干预措施: Recombinant Interferon Alfa (Biological)
Arm IV
Interferon alfa as in arm III at a higher dose.
干预措施: Recombinant Interferon Alfa (Biological)
Arm III
Interferon alfa SC once daily.
干预措施: Recombinant Interferon Alfa (Biological)
Arm II
Interferon alfa as in arm I at a higher dose.
干预措施: Recombinant Interferon Alfa (Biological)
结局指标
主要结局
Descriptive Data on Expression of Death Effectors in Context of Low-dose Interferon
时间窗: 2 Years
Data collection continues with treatment in absence of unacceptable toxicity.
次要结局
未报告次要终点