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

This study is currently recruiting participants.
Verified February 2010 by West Penn Allegheny Health System
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Primary Glial Neoplasms of Brain
Glioblastoma
 Drug: Aminolevulinic Acid
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain.

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer
U.S. FDA Resources

Further study details as provided by West Penn Allegheny Health System:

Primary Outcome Measures:
  • More complete resection of malignant brain tumors [ Time Frame: 3-7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of drug [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: September 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aminolevulinic Acid 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00961090

Contacts
Contact: Dorothy Packer, RN,BSN 412-359-6505 dpacker@wpahs.org
Contact: Diane Cantella, RN,BSN 412+359-3353 dcantell@wpahs.org

Locations
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Dorothy M Packer, RN, BSN     412-359-6505        
Sponsors and Collaborators
West Penn Allegheny Health System
DUSA Pharmaceuticals, Inc.
Investigators
Principal Investigator: Matthew R Quigley, MD West Penn Allegheny Health System
  More Information

No publications provided

Responsible Party: Matthew R. Quigley, MD Director, Division of Neuro-Oncology, Allegheny General Hospital
ClinicalTrials.gov Identifier: NCT00961090     History of Changes
Other Study ID Numbers: 104974
Study First Received: August 17, 2009
Last Updated: June 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by West Penn Allegheny Health System:
Brain tumor
glioma
surgical resection
ALA
ultraviolet light

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Glioblastoma
Glioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Astrocytoma
Neoplasms, Neuroepithelial
 Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Aminolevulinic Acid
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013