Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of Participants With Complete Response
研究概览
简要总结
Kaposi sarcoma remains the most common malignancy among persons with HIV.
Lesions localized to the airway may cause bleeding, pain and dyspnea.
New therapeutic approaches for local disease are needed.
The purpose of this study is to compare the effectiveness of intralesional bevacizumab + HAART vs HAART alone in treating localized Kaposi´s sarcoma of the airway in patients with AIDS.
详细描述
Once disseminated disease is excluded, histologically confirmed HIV-positive patients with localized Kaposi's sarcoma of the airway will be randomized to receive HAART only or HAART + intralesional bevacizumab.
The primary outcome will be the size of lesions according to RECIST criteria. Patients in the HAART + bevacizumab arm will undergo series of 3 bevacizumab injections of 5 mg/cm3. Follow-up will be carried out through scheduled meetings for office setting examination every week for the first 8 weeks, then every 15 days for two months and finally every month for eight months.
Size of the lesions will be assessed by an independent observer and adverse events will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infected
- •KS of the oral cavity, pharynx and larynx, histopathologically confirmed
- •HIV treatment-naïve
排除标准
- •Airway obstructive lesions
- •Actively bleeding lesions
- •Tumor-associated oedema or ulceration
- •Gastrointestinal KS
- •KS in other nonnodal viscera
研究组 & 干预措施
HAART+ Bevacizumab injection
Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Patients received 3 intralesional injections of bevacizumab (Avastin, Genentech, San Francisco, California) in the target lesion every 2 weeks. Bevacizumab was injected using an insulin syringe in a submucosal plane. The volume injected was based on the size of the target lesion; the dose was 0.2 mL (5 mg) per cm2.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Number of Participants With Complete Response
时间窗: 12 months
Complete response will be assessed according to RECIST criteria
次要结局
- Safety(12 months)
研究者
Gustavo Reyes-Teran
Gustavo Reyes-Teran
Centro de Investigación en. Enfermedades Infecciosas, Mexico