A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

Conditions
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Malignant Glioma, Glioma, Glioblastoma, Glioblastoma Multiforme, Astrocytoma

Intervention / Treatment
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* Drug: Aminolevulinic Acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aminolevulinic Acid (AL)<br> | Drug: Aminolevulinic Acid<br>* Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.<br>* Other names: Levulan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression after initial surgery. | Determine time-to-progression compared to that in comparable cases performed without the aid of ALA. | Up to 2 years | 
| Complete Resection | Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the number of subjects with adverse events due to ALA in this dosage and indication. | Subjects will be followed closely for adverse events including biochemical abnormalities through laboratory monitoring and for clinically evident adverse events including possible skin reactions that may occur. | Through 45 days | 
| Overall Survival | Determine the overall survival compared to historical controls. | Up to three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioma, Glioblastoma, Glioblastoma Multiforme, Astrocytoma, Brain Tumor