NCT00002105已完成3 期
Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma
Sequus Pharmaceuticals7 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 7
研究概览
简要总结
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS.
详细描述
Patients are randomized to receive either DOX-SL or the BV combination. Infusions are given on day 1 and every 3 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. Patients who respond to therapy will be followed every 2 months for up to 1 year. Patients must agree to have one or more representative KS lesions biopsied.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
- •Concurrent Medication:
- •Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month.
- •Maintenance therapy for tuberculosis, fungal, and herpes infections.
- •Therapy for new episodes of tuberculosis, fungal, and herpes infection except with potentially myelotoxic chemotherapy.
- •Foscarnet for cytomegalovirus infection.
- •Erythropoietin.
- •Patients must have:
- •Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:
- •At least 15 mucocutaneous lesions.
- •Six or more new lesions in the prior month.
- •Documented visceral disease with at least five accessible cutaneous lesions.
- •Documented anti-HIV antibody.
- •No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if REQUIRING treatment with myelotoxic drugs).
- •Life expectancy > 4 months.
- •Patients who fail the BV combination or who relapse are eligible to enter the Liposome Technology open trial using DOX-SL alone.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Clinically significant cardiac disease.
- •Confusion, disorientation, CNS symptoms, or peripheral neuropathy.
- •Concurrent Medication:
- •Other cytotoxic chemotherapy.
- •Colony-stimulating factors.
- •Ganciclovir.
- •Patients with the following prior conditions are excluded:
- •Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function.
- •History of idiosyncratic or allergic reaction to anthracyclines, bleomycin, or vincristine.
- •History of major psychiatric illness.
- •Prior Medication:
- •Cytotoxic chemotherapy or interferon therapy within the past 4 weeks.
- •More than one prior cycle of bleomycin/vincristine at any time.
- •Prior Treatment:
- •Radiation or electron beam therapy within the past 3 weeks.
研究者
研究点 (7)
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