Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Changes in the annual surgery rate
研究概览
简要总结
The aim of this study is to compare the efficacy of intralesional bevacizumab, a monoclonal antibody against vascular endothelial growth factor, versus the antiviral drug cidofovir in patients with recurrent respiratory papillomatosis.
详细描述
The investigators designed a randomized, double-blind, placebo-controlled study. Children and adults will be randomized to receive either 3 dosis of intralesional bevacizumab, cidofovir or saline solution. Primary endpoints are the assessment of changes in the annual surgery rate and Derkay papilloma severity grading scale; secondary endpoints are changes in the Voice Handicap Index and safety.
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
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with recurrent respiratory papillomatosis proven by biopsy.
- •Patients with 2 or more previous surgeries for papillomatosis
排除标准
- •Patients with heart or renal disease
- •Patients who receive another adjuvant therapy
研究组 & 干预措施
Bevacizumab
Patients will receive 3 intralesional injections of bevacizumab (Avastin, Genentech, San Francisco, California) every 3 to 6 weeks in a submucosal plane after surgical debulking. 12.5 mg of bevacizumab diluted in 3mL of 9% isotonic sodium chloride solution will be injected intralesionally using a 25 gauge.
干预措施: Bevacizumab (Drug)
Cidofovir
Patients will receive 3 intralesional injections of cidofovir every 3 to 6 weeks a submucosal plane after surgical debulking. 3.5 mL of cidofovir diluted to a concentration of 5 mg/mL in a 9% isotonic sodium chloride solution will be injected intralesionally using a 25 gauge.
干预措施: Cidofovir (Drug)
Saline
Patients will receive 3 intralesional injections of 3.5 mL of saline solution every 3 to 6 weeks in a submucosal plane after surgical debulking.
干预措施: Placebo (Other)
结局指标
主要结局
Changes in the annual surgery rate
时间窗: 12 months
Changes in the annual surgery rate before and after intervention
Severity of airway affection measured by the Derkay papilloma severity grading scale
时间窗: 12 months
Changes in the Derkay papilloma severity grading scale before and after intervention
次要结局
- Number of Treatment-Related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE)(12 months)
- Hoarseness severity measured by the Voice Handicap Index(12 months)
研究者
Gustavo Reyes-Teran
M.D.
Centro de Investigación en. Enfermedades Infecciosas, Mexico