Treatment of HIV-Related Primary Central Nervous System Lymphoma (HIV-PCNSL): A Phase II Trial With Neoadjuvant Chemotherapy (High-Dose Methotrexate (MTX) Plus High-Dose Zidovudine) and Radiotherapy
试验速览
- 阶段
- 2 期
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Efficacy
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. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving methotrexate and zidovudine together with radiation therapy works in treating patients with HIV-related primary central nervous system lymphoma.
详细描述
OBJECTIVES:
- Determine the efficacy of neoadjuvant chemotherapy and radiation therapy in the treatment of HIV-related primary CNS lymphoma patients.
- Evaluate the toxicity and overall survival of these patients.
OUTLINE: Patients receive chemotherapy consisting of high-dose methotrexate IV administered on day 1 and high-dose zidovudine IV administered on days 1-3 every 2 weeks. Patients receive 3 courses of therapy. Following chemotherapy, patients receive radiation therapy to the lesion site daily.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: This study will accrue 14 patients.
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 proven HIV-related non-Hodgkin's lymphoma of the CNS
- •No systemic lymphoma
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3000/mm^3
- •Platelet count at least 80,000/mm^3
- •No serious impairment of liver function
- •No serious impairment of renal function
- •Creatinine clearance at least 40 mL/min
- •Cardiovascular:
- •No serious impairment of cardiac function
- •Neurologic:
- •Neurological functional status 0-3
- •No prior or active CNS-opportunistic infections
- •No AIDS dementia complex
- •No active systemic infections
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy or radiotherapy
排除标准
- 未提供
结局指标
主要结局
Efficacy
Toxicity
Overall survival
次要结局
未报告次要终点