A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors
Primary Purpose
Malignant Glioma, Glioma, Glioblastoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aminolevulinic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Glioma focused on measuring Glioma, Glioblastoma, Glioblastoma Multiforme, Astrocytoma, Brain Tumor
Eligibility Criteria
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.
Sites / Locations
- MultiCare Health System Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aminolevulinic Acid (AL)
Arm Description
Outcomes
Primary Outcome Measures
Time to disease progression after initial surgery.
Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.
Complete Resection
Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls
Secondary Outcome Measures
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.
Overall Survival
Determine the overall survival compared to historical controls.
Full Information
NCT ID
NCT01351519
First Posted
May 7, 2011
Last Updated
March 15, 2016
Sponsor
MultiCare Health System Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01351519
Brief Title
A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors
Official Title
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Limited staff available for enrollment and limited availability of drug
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MultiCare Health System Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma, Glioma, Glioblastoma, Glioblastoma Multiforme, Astrocytoma
Keywords
Glioma, Glioblastoma, Glioblastoma Multiforme, Astrocytoma, Brain Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aminolevulinic Acid (AL)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aminolevulinic Acid
Other Intervention Name(s)
ALA, 5-Aminolevulinic Acid, Levulan
Intervention Description
Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.
Primary Outcome Measure Information:
Title
Time to disease progression after initial surgery.
Description
Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.
Time Frame
Up to 2 years
Title
Complete Resection
Description
Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
Determine the number of subjects with adverse events due to ALA in this dosage and indication.
Description
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.
Time Frame
Through 45 days
Title
Overall Survival
Description
Determine the overall survival compared to historical controls.
Time Frame
Up to three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Morris, MD
Organizational Affiliation
MultiCare Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Shine, PharmD, BCPS
Organizational Affiliation
MultiCare Health System Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
MultiCare Health System Research Institute
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16648043
Citation
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.
Results Reference
result
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A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors
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