A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors
| Status: | Terminated |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2011 |
| End Date: | January 2015 |
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
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.
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.
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.
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.
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.
-Ability to provide informed consent or consent from a Legally Authorized Representative.
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.
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