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Limited staff available for enrollment and limited availability of drug
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aminolevulinic Acid (AL) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminolevulinic Acid | Drug | Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery. |
|
| 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 |
| 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| William Morris, MD | MultiCare Health System | Principal Investigator |
| Richard Shine, PharmD, BCPS | MultiCare Health System Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MultiCare Health System Research Institute | Tacoma | Washington | 98405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16648043 | Result | Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9. |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Overall Survival |
Determine the overall survival compared to historical controls. |
| Up to three years |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |