Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 59
研究概览
简要总结
To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who previously had good responses to DOX-SL in controlled studies of limited duration, or those with KS who discontinued treatment with another Kaposi's sarcoma therapy because of inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's sarcoma patients for whom DOX-SL therapy is indicated.
详细描述
Patients receive DOX-SL every 3 weeks for a maximum of 20 cycles (including any cycles from a previous DOX-SL study). KS lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. Patients who respond will be followed every 2 months for up to 1 year. Study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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 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 infections except with potentially myelotoxic chemotherapy.
- •Foscarnet or ganciclovir for CMV infection.
- •Colony stimulating factors and erythropoietin.
- •Patients must have:
- •Moderate to severe AIDS-related Kaposi's sarcoma.
- •Documented anti-HIV antibody.
- •No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).
- •Eligible KS patients include those who have discontinued therapy in the control arm of a DOX-SL KS study because of side effects or inadequate efficacy OR other KS patients for whom DOX-SL is believed to be indicated. Patients must not be eligible for other Liposome Technology protocols comparing DOX-SL with established therapies.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Clinically significant cardiac disease.
- •Confusion or disorientation.
- •Concurrent Medication:
- •Other cytotoxic cancer chemotherapy.
- •Patients with the following prior conditions are excluded:
- •Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function.
- •History of idiosyncratic or allergic reaction to anthracyclines.
- •History of major psychiatric illness.
- •Prior Medication:
- •Excluded within the past 4 weeks:
- •Cytotoxic chemotherapy (other than in a qualifying Liposome Technology protocol).
- •Interferon treatment.
- •Prior Treatment:
- •Excluded within the past 3 weeks:
- •Radiation or electron beam therapy.