Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- serious adverse event (SAE) Rate
研究概览
简要总结
This research is being done to study the safety and utility of 5-aminolevulinic acid (5-ALA) (also known as Gliolan) for identifying brain tumor tissue during surgery. The goal of this study is to determine if 5-ALA can differentiate between tumor and normal brain tissue.
Sometimes, during brain surgery, the removal of tumor tissue can be difficult because the tumor can look like normal brain tissue. Studies in other countries have shown that in some brain tumors, 5-ALA can make the tumors appear brighter under ultraviolet light. This may make it easier for doctors to remove as much tumor as safely as possible from your brain.
This study also hopes to see if 5-ALA can find different cell populations within the tumor that is removed and allow the researchers to better understand brain tumors.
The purpose of this study is to:
- Find out how well 5-ALA can separate normal brain tissue from tumor tissues AND to see how well 5-ALA can find different cell populations within brain tumors
- Identify the amount of 5-ALA that should be taken before surgery to make the tumors glow under ultraviolet light
- Make sure the 5-ALA identifies tumor and not normal brain
- Make sure 5-ALA does not cause any side effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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. Radiographic findings should be consistent with high grade glioma. Intraoperative frozen section should either be: anaplastic astrocytoma (WHO Grade III astrocytoma) or glioblastoma (WHO Grade IV astrocytoma).
- •Patients must be aged greater than 18 years old
- •Karnofsky Performance Score > 70 (Appendix)
- •Patients must have normal organ and marrow function as defined below:
- •Leukocytes > 3,000 /uL
- •Absolute neutrophil count > 1,500/uL
- •Platelets > 100,000/uL
- •Total bilirubin within normal institutional limits
- •AST/ALT within normal institutional limits
- •Creatinine within normal institutional limits
排除标准
- •Prior craniotomy for resection, deep seated tumors in thalamus and brain stem.
- •History of allergic reactions to compounds of similar chemical composition to ALA.
- •Personal or family history of porphyrias
- •Personal history of hepatitis or other liver diseases.
- •Pregnant women are excluded from this study because ALA is of unknown teratogenic effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ALA, breastfeeding should be discontinued prior to treatment with ALA.
- •Inability to undergo magnetic resonance imaging (i.e. those patients with AICD/pacemakers).
研究组 & 干预措施
5-ALA
This arm will receive the investigational agent, 5-ALA.
干预措施: 5-Aminolevulinic Acid (Drug)
结局指标
主要结局
serious adverse event (SAE) Rate
时间窗: 2 weeks from dosing
It will be considered as a serious adverse event with possible, probable, and definitely attribution to 5-ALA (SAE, detailed in section 8) if (within 2 weeks of dosing): Grade 1 or 2 LFT abnormalities not resolving within 2 weeks A single documented Grade 3 or 4 LFT abnormalities A Grade 3 or 4 skin photosensitivity
次要结局
- Diagnostic Accuracy(72 hours post-operative)