A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
To determine the efficacy of Pulse Reduced Dose Rate (PRDR) radiation when given in 27 fraction over 5.5 weeks with concurrent bevacizumab followed by adjuvant bevacizumab until time of progression in patients with recurrent high grade gliomas (grade III and grade IV). Patients will be placed in 1 of 4 groups based on their histologic diagnosis and prior exposure to bevacizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or molecularly confirmed Grade 3 or 4 glioma, IDH mutant or wildtype, as defined by the 2021 WHO guidelines
- •Recurrent disease based on combination of clinical, imaging or histologic confirmation
- •Must have previously received radiation and temozolomide to treat their glioma
- •Bevacizumab naive patients must be > 5 months post completion of initial radiation therapy
- •Bevacizumab exposed patients must be > 3 months post completion of initial radiation therapy
- •Age must be >18years, KPS must be greater than 60
- •Hematology, chemistry and a urinalysis must meet protocol specified criteria
排除标准
- •Pregnant or breastfeeding
- •Uncontrolled hypertension (>160/90mmHg)
- •Prior malignancy unless treated >1 year prior to study and have been without treatment and disease free for 1 yr
- •active second malignancy unless non-melanoma skin cancer or cervical cancer in situ
研究组 & 干预措施
Bevacizumab-naïve with recurrent IDH wildtype high grade glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
干预措施: Bevacizumab (Drug)
Bevacizumab-naïve with recurrent IDH wildtype high grade glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
干预措施: PRDR (Radiation)
Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
干预措施: Bevacizumab (Drug)
Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
干预措施: PRDR (Radiation)
Bevacizumab-naïve with recurrent IDH mutant glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
干预措施: Bevacizumab (Drug)
Bevacizumab-naïve with recurrent IDH mutant glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
干预措施: PRDR (Radiation)
Bevacizumab-exposed with recurrent IDH mutant glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
干预措施: Bevacizumab (Drug)
Bevacizumab-exposed with recurrent IDH mutant glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
干预措施: PRDR (Radiation)
结局指标
主要结局
Overall survival
时间窗: end of study, which will be an average of 12 months
time of first dose of PDRD+ Bevacizumab until time of death
次要结局
- Change in Mini Mental State Exam (MMSE) Score(baseline and then approximately every 8 weeks for 18 months)
- progression free survival(at 3 months for bevacizumab exposed patients, at 6 and 12 months for all patients)
- Change in Participant Reported FACIT-F Score(baseline and then approximately every 8 weeks for 18 months)
- Incidence of Late Toxicities(from 90 days post radiotherapy until time of death)
- Incidence of Adverse Events(up to 30 days post last dose of bevacizumab)
- Change in Participant Reported FACT-BR Score(baseline and then approximately every 8 weeks for 18 months)
- Change in Karnofsky Performance Status(baseline and then approximately every 8 weeks for 18 months)