Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related Lymphoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Effects of treatment on response rate, time to disease progression, and survival
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. Combining more than one drug may kill more cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase I/II trial to study the effectiveness of combining filgrastim with combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the toxicity of mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone, and filgrastim (G-CSF) in patients with good-prognosis (defined by the study as having 1 adverse prognostic factor) HIV-related non-Hodgkin's lymphoma.
- Determine the effects of this regimen on response rate, time to disease progression, and survival in these patients.
OUTLINE: This is a multicenter study.
Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; and vincristine IV and bleomycin IV on day 8. Patients also receive prednisolone daily on weeks 1-4 and then every other day on weeks 5-16. Patients receive filgrastim (G-CSF) subcutaneously on days 6-12. Treatment repeats every 2 weeks for up to 8 courses (16 weeks) in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) receive 4 courses beyond CR or PR.
Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed previously untreated HIV-related non-Hodgkin's lymphoma with 1 of the following:
- •Prior diagnosis of acquired immune deficiency syndrome (AIDS)
- •CD4 count < 100,000/mm3
- •ECOG performance status > 2
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •See Disease Characteristics
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •Not specified
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Effects of treatment on response rate, time to disease progression, and survival
Toxicity
次要结局
未报告次要终点