Trial record 8 of 750 for:    ALA

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
  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:


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
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

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

ClinicalTrials.gov processed this record on September 16, 2014