A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Complete Resection
研究概览
简要总结
In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue improves the surgeon's ability to completely resect or remove the brain tumor.
详细描述
This is a Phase 2 study and all subjects will receive open label Aminolevulinic Acid in a dose of 20mg/kg given orally 3 hours prior to surgery. Brain tumors will be resected with the aid of ultraviolet light to visualize the tumor. After surgery an MRI will be done to determine whether the tumor has been completely or partially resected. All subjects will be followed for safety. All subjects will be followed closely by clinical examination and by MRI to monitor for disease recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Clinically documented primary brain tumor for which surgical resection is indicated.
- •Age 18 years and older.
- •ECOG Performance status less than or equal to
- •Laboratory values as follows:
- •Leukocytes greater than or equal to 3,
- •ANC greater than or equal to 1,
- •Platelets greater than or equal to 100,
- •Total Bilirubin WNL. AST/ALT less than or equal to 2.5 times ULN. Creatinine WNL. or Creatinine Clearance greater than or equal to 60ml/min/1.73m2 if SCr above institutional normal.
- •Ability to provide informed consent or consent from a Legally Authorized Representative.
排除标准
- •Receipt of an investigational agent within 30 days.
- •Allergy to ALA or similar compounds.
- •Personal or family history of porphyria.
- •Uncontrolled intercurrent illness.
- •Inability to comply with the protocol.
- •Pregnancy, breastfeeding.
研究组 & 干预措施
Aminolevulinic Acid (AL)
干预措施: Aminolevulinic Acid (Drug)
结局指标
主要结局
Complete Resection
时间窗: Day 2
Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls
Time to disease progression after initial surgery.
时间窗: Up to 2 years
Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.
次要结局
- Overall Survival(Up to three years)
- Determine the number of subjects with adverse events due to ALA in this dosage and indication.(Through 45 days)