Astrocytoma, Glioblastoma, Glioblastoma Multiforme, Glioma, Malignant Glioma
Conditions
Keywords
Glioma, Glioblastoma, Glioblastoma Multiforme, Astrocytoma, Brain Tumor
Brief summary
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
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.
Interventions
DRUGAminolevulinic Acid
Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.
Sponsors
MultiCare Health System Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to disease progression after initial surgery. | Up to 2 years | Determine time-to-progression compared to that in comparable cases performed without the aid of ALA. |
| Complete Resection | Day 2 | Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the number of subjects with adverse events due to ALA in this dosage and indication. | Through 45 days | 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. |
| Overall Survival | Up to three years | Determine the overall survival compared to historical controls. |
Countries
United States
Outcome results
None listed