- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01351519
A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Washington
-
Tacoma, Washington, United States, 98405
- MultiCare Health System Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aminolevulinic Acid (AL)
|
Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to disease progression after initial surgery.
Time Frame: Up to 2 years
|
Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.
|
Up to 2 years
|
Complete Resection
Time Frame: Day 2
|
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.
Time Frame: 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.
|
Through 45 days
|
Overall Survival
Time Frame: Up to three years
|
Determine the overall survival compared to historical controls.
|
Up to three years
|
Collaborators and Investigators
Investigators
- Principal Investigator: William Morris, MD, MultiCare Health System
- Study Director: Richard Shine, PharmD, BCPS, MultiCare Health System Research Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALA 11.07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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