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Therapeutic Areas: Oncology | Neurology
Disease Category: Gliomas
Location: United States, WA
Clinical Trial Details
Research Study Summary
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
The purpose of this study is to determine the safety and usefulness of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. When your doctor removes the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors ALA can make the tumors glow red under ultraviolet light (a "black light"). This may make it easier for your doctor to identify and remove more tumor tissue.
Patient Inclusion Criteria:
- Clinically documented primary brain tumor for which surgical resection is indicated.
- Age 18 years and older.
- ECOG Performance status less than or equal to 2.
- Laboratory values as follows:
- Leukocytes greater than or equal to 3,000. ANC greater than or equal to 1,500. Platelets greater than or equal to 100,000. 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.
Patient Exclusion Criteria:
- 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.
To Learn more
Both Male and Female
Date Last Changed:
July 16, 2013
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