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
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively
研究概览
简要总结
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.
详细描述
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing brain tumors during surgery. When ALA is provided at an increased concentration, protoporphorin concentration in the malignant cell increases and renders the cell fluorescent under long ultraviolet light. This study looks at using oral ALA to help identify the tumor cells intraoperatively and facilitate complete resection.
Oral ALA will be given prior to image-guided microsurgical resection of the tumor. Following tumor resection under light microscopy, the tumor bed will be illuminated and any residual fluorescent tissue in cavity will be surgically removed leading to a more complete resection of tumor. Pathologic confirmation of tumor type will be made by neuropathology. Photosensitizer concentration in malignant and normal tissue will be estimated by fluorescence microscopy.
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
- •Patients must have clinically documented primary brain tumor for which resection is clinically indicated. The anticipated histology at resection should include: Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed astrocytoma-ependymoma
- •Patients may have prior therapy
- •18 years of age
- •Male or Female
- •Life expectancy is not a consideration for protocol entry
- •Patients must have normal organ and marrow function as defined below: Leukocytes >3,000/mL, Absolute neutrophil count >1,500/mL, Platelets >100,000/mL, Total bilirubin within normal institutional limits AST (SGOT)/ALT (SGPT)<2.5 X institutional upper limit of normal, Creatinine within normal institutional limits or Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- •Confirmation of Glial Tumor
- •Gross total resection is the aim of surgery
- •Ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign a written informed consent.
排除标准
- •Non-Glial tumor i.e. tumor abscess, metastasis, lymphoma, vasculitis
- •Tumor with perforating vessels
- •Tumor involves critical fiber tracks
- •Use of the microsurgical tool monopolar loop
- •Subject has preexisting severe deficits concerning language or motor function not resolved with steroids
- •Performance Status of less than 60
- •Prior therapy is not an exclusion criterion
- •Patients may not be receiving any other investigational agents
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA)
- •Personal or family history of porphorias
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
ALA
5-Aminolevuline Acid (ALA)
干预措施: 5-Aminolevuline Acid (Drug)
结局指标
主要结局
Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively
时间窗: participants will be followed while in the hospital and for 12 weeks after surgery
次要结局
- Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA(participants will be followed for 24 months)
研究者
Jefferson W Chen, MD
Principal Investigator
Legacy Health System