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

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
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:

MedlinePlus related topics: Cancer

Drug Information available for: Aminolevulinic acid Aminolevulinic acid hydrochloride

Genetic and Rare Diseases Information Center resources: Glioblastoma Glioma Neuroepithelioma

U.S. FDA Resources

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:

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 September 26, 2016

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