NCT00002348已完成2 期
Phase II Evaluation of Mitoguazone Dihydrochloride in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma Associated With Acquired Immunodeficiency Syndrome
Genzyme, a Sanofi Company2 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
To estimate the response rate, response duration, clinical benefit, and toxicity of mitoguazone dihydrochloride (MGBG) in patients with AIDS-related refractory or relapsing non-Hodgkin's lymphoma (NHL).
详细描述
Patients receive infusions of MGBG on days 1 and 8 and every 2 weeks thereafter. It is suggested that a lumbar puncture be performed to evaluate for leptomeningeal disease.
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
- •Patients must have:
- •HIV positivity by ELISA confirmed by Western blot.
- •AIDS-related NHL that is refractory or relapsed.
- •Life expectancy of at least 12 weeks.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms and conditions are excluded:
- •Concomitant malignancy OTHER THAN curatively treated carcinoma in situ of the cervix; basal or squamous cell carcinoma of the skin; or non-active, non-visceral Kaposi's sarcoma not requiring active chemotherapy.
- •Active uncontrolled bacterial infection, viral infection (other than herpes simplex), or fungal infection (other than oropharyngeal candidiasis) that requires treatment within 2 weeks of study entry.
- •Significant cardiovascular disease.
- •Concurrent Medication:
- •Hormonal therapy (except medications given for muscle wasting, such as testosterone or Megace).
- •Other chemotherapy.
- •Investigational anti-cancer drugs.
- •Concurrent Treatment:
- •Concomitant radiation to sites other than CNS.
- •Patients with the following prior conditions are excluded:
- •Prior malignancy OTHER THAN curatively treated carcinoma in situ of the cervix; basal or squamous cell carcinoma of the skin; or non-active, non-visceral Kaposi's sarcoma not requiring active chemotherapy.
- •Recommended:
- •Prophylaxis for PCP and oral candidiasis.
- •Required in patients with leptomeningeal disease:
- •Intrathecal methotrexate or cytarabine (Ara-C).
- •Leucovorin.
- •Required in patients with leptomeningeal disease:
- •Cranial radiation to a helmet field.
研究者
研究点 (2)
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