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
  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
Glioblastoma
Drug: Aminolevulinic Acid
Phase 2

Study Type: Interventional
Study Design: 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:


Further study details as provided by Allegheny Singer Research Institute:

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 ]

Enrollment: 150
Study Start Date: September 2009
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Aminolevulinic Acid
    20 mg/kg mixed in water and taken orally prior to surgery
Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 porphyrias
  • Liver disease in the past year
  • Uncontrolled intercurrent illness
  • Pregnant or lactating women
  • Inability to undergo MRI with contrast
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Diane Cantella
DUSA Pharmaceuticals, Inc.
Investigators
Principal Investigator: Matthew R Quigley, MD The Guthrie Clinic
  More Information

Responsible Party: Diane Cantella, co-investigator, Allegheny Singer Research Institute
ClinicalTrials.gov Identifier: NCT00961090     History of Changes
Other Study ID Numbers: 104974 
Study First Received: August 17, 2009
Last Updated: September 21, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Allegheny Singer Research Institute:
Brain tumor
glioma
surgical resection
ALA
ultraviolet light

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 28, 2016