Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery

This study has been completed.
Sponsor:
Collaborator:
DUSA Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Diane Cantella, Allegheny Singer Research Institute
ClinicalTrials.gov Identifier:
NCT00961090
First received: August 17, 2009
Last updated: September 21, 2015
Last verified: September 2015

August 17, 2009
September 21, 2015
September 2009
August 2015   (final data collection date for primary outcome measure)
More complete resection of malignant brain tumors [ Time Frame: 3-7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00961090 on ClinicalTrials.gov Archive Site
Safety of drug [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain.
A one time oral dose of ALA is taken before surgery. The medication makes the tumor visible under ultraviolet light which allow the surgeon to see more of the tumor for a more complete removal.
Patients with primary neoplastic brain tumors (Grades II-IV) will participate in this trial. Each patient will have been evaluated and found to have such a tumor by history and recent imaging studies (MRI) and deemed a surgical candidate based on current neurosurgical standards of care.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma
Drug: Aminolevulinic Acid
20 mg/kg mixed in water and taken orally prior to surgery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
August 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Suspected primary brain tumor
  • 18 years of age or more
  • Normal marrow and organ function
  • Life expectancy not a consideration

Exclusion Criteria:

  • Receiving any other investigational agents
  • History of allergic reactions to ALA
  • Personal or family history of porphyrias
  • Liver disease in the past year
  • Uncontrolled intercurrent illness
  • Pregnant or lactating women
  • Inability to undergo MRI with contrast
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00961090
104974
Yes
Not Provided
Not Provided
Diane Cantella, Allegheny Singer Research Institute
Diane Cantella
DUSA Pharmaceuticals, Inc.
Principal Investigator: Matthew R Quigley, MD The Guthrie Clinic
Allegheny Singer Research Institute
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP