NCT00002188已完成2 期
Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
研究概览
简要总结
The purpose of this study is to see if ALRT1057 is safe and effective in treating patients with AIDS-related Kaposi's sarcoma (KS).
详细描述
Patients receive open-label ALRT1057 for 16 weeks, as tolerated. In the absence of unacceptable toxicity, patients may continue treatment indefinitely provided they continue to benefit from therapy and the study remains open and active.
Thirteen patients are treated initially. If at least one response is observed in these patients, up to 14 additional patients will be evaluated.
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 positive status and histologic confirmation of KS.
- •CD4 count > 200 mm3 (required of one-half of patients).
- •Minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions meeting criteria for "indicator" lesions.
- •Acceptable organ system function.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Serious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program.
- •Prior Medication:
- •Systemic therapy for KS within 30 days.
- •Local or topical therapy for KS indicative lesions within 60 days.
- •Systemic therapy with vitamin A in doses exceeding 15,000 IU per day or other retinoid class drug.
- •Approved antiretroviral therapy.
研究者
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