Back to resultsA Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain (ALA)
Primary Purpose
Glioma
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
5-Aminolevuline Acid
Sponsored by
About this trial
This is an interventional treatment trial for Glioma focused on measuring Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed astrocytoma-ependymoma, ALA
Eligibility Criteria
Inclusion Criteria:
- Patients must have clinically documented primary brain tumor for which resection is clinically indicated. The anticipated histology at resection should include: Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed astrocytoma-ependymoma
- Patients may have prior therapy
- 18 years of age
- Male or Female
- Life expectancy is not a consideration for protocol entry
- Patients must have normal organ and marrow function as defined below: Leukocytes >3,000/mL, Absolute neutrophil count >1,500/mL, Platelets >100,000/mL, Total bilirubin within normal institutional limits AST (SGOT)/ALT (SGPT)<2.5 X institutional upper limit of normal, Creatinine within normal institutional limits or Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Confirmation of Glial Tumor
- Gross total resection is the aim of surgery
- Ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
- Non-Glial tumor i.e. tumor abscess, metastasis, lymphoma, vasculitis
- Tumor with perforating vessels
- Tumor involves critical fiber tracks
- Use of the microsurgical tool monopolar loop
- Subject has preexisting severe deficits concerning language or motor function not resolved with steroids
- Performance Status of less than 60
- Prior therapy is not an exclusion criterion
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA)
- Personal or family history of porphorias
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Sites / Locations
- Legacy Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ALA
Arm Description
5-Aminolevuline Acid (ALA)
Outcomes
Primary Outcome Measures
Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively
Secondary Outcome Measures
Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA
Full Information
NCT ID
NCT01403311
First Posted
July 25, 2011
Last Updated
March 24, 2014
Sponsor
Legacy Health System
Collaborators
DUSA Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01403311
Brief Title
A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
Acronym
ALA
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 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
March 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Legacy Health System
Collaborators
DUSA Pharmaceuticals, Inc.
4. Oversight
5. Study Description
Brief Summary
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.
Detailed Description
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing brain tumors during surgery. When ALA is provided at an increased concentration, protoporphorin concentration in the malignant cell increases and renders the cell fluorescent under long ultraviolet light. This study looks at using oral ALA to help identify the tumor cells intraoperatively and facilitate complete resection.
Oral ALA will be given prior to image-guided microsurgical resection of the tumor. Following tumor resection under light microscopy, the tumor bed will be illuminated and any residual fluorescent tissue in cavity will be surgically removed leading to a more complete resection of tumor. Pathologic confirmation of tumor type will be made by neuropathology. Photosensitizer concentration in malignant and normal tissue will be estimated by fluorescence microscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed astrocytoma-ependymoma, ALA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALA
Arm Type
Experimental
Arm Description
5-Aminolevuline Acid (ALA)
Intervention Type
Drug
Intervention Name(s)
5-Aminolevuline Acid
Intervention Description
5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before surgery
Primary Outcome Measure Information:
Title
Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively
Time Frame
participants will be followed while in the hospital and for 12 weeks after surgery
Secondary Outcome Measure Information:
Title
Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA
Time Frame
participants will be followed for 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have clinically documented primary brain tumor for which resection is clinically indicated. The anticipated histology at resection should include: Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed astrocytoma-ependymoma
Patients may have prior therapy
18 years of age
Male or Female
Life expectancy is not a consideration for protocol entry
Patients must have normal organ and marrow function as defined below: Leukocytes >3,000/mL, Absolute neutrophil count >1,500/mL, Platelets >100,000/mL, Total bilirubin within normal institutional limits AST (SGOT)/ALT (SGPT)<2.5 X institutional upper limit of normal, Creatinine within normal institutional limits or Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Confirmation of Glial Tumor
Gross total resection is the aim of surgery
Ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
Non-Glial tumor i.e. tumor abscess, metastasis, lymphoma, vasculitis
Tumor with perforating vessels
Tumor involves critical fiber tracks
Use of the microsurgical tool monopolar loop
Subject has preexisting severe deficits concerning language or motor function not resolved with steroids
Performance Status of less than 60
Prior therapy is not an exclusion criterion
Patients may not be receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA)
Personal or family history of porphorias
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jefferson Chen, MD, PhD
Organizational Affiliation
Legacy Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Legacy Health System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
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