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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by West Penn Allegheny Health System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
DUSA Pharmaceuticals, Inc.
Information provided by:
West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT00961090
First received: August 17, 2009
Last updated: June 27, 2011
Last verified: February 2010

August 17, 2009
June 27, 2011
September 2009
August 2013   (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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Glial Neoplasms of Brain
  • Glioblastoma
  • Drug: Aminolevulinic Acid
    20mg/kg in a one time oral dose re-constituted in 50 cc of water.
    Other Names:
    • Aminolevulinic Acid
    • ALA
  • Drug: Aminolevulinic Acid
    20 mg/kg dissolved in 50 cc water taken orally 3 hours before surgery
    Other Names:
    • ALA
    • 5ALA
Experimental: Aminolevulinic Acid
Interventions:
  • Drug: Aminolevulinic Acid
  • Drug: Aminolevulinic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
October 2013
August 2013   (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 prophorias
  • Liver disease in the past year
  • Uncontrolled intercurrent illness
  • Pregnant or Lactating women
  • Inability to undergo MRI with contrast
Both
18 Years and older
No
Contact: Dorothy Packer, RN,BSN 412-359-6505 dpacker@wpahs.org
Contact: Diane Cantella, RN,BSN 412+359-3353 dcantell@wpahs.org
United States
 
NCT00961090
104974
Yes
Matthew R. Quigley, MD Director, Division of Neuro-Oncology, Allegheny General Hospital
West Penn Allegheny Health System
DUSA Pharmaceuticals, Inc.
Principal Investigator: Matthew R Quigley, MD West Penn Allegheny Health System
West Penn Allegheny Health System
February 2010

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