A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

Status unconfirmed · Phase 2

Conditions studied: Glioma

In brief

This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.

Key facts

Study ID: NCT01403311
Run by: Legacy Health System
People needed: 18
Starts: 2010-10-01
Expected to finish: 2015-03-01
Last updated by the study team: 2014-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have clinically documented primary brain tumor for which resection is clinically indicated. The anticipated histology at resection should include: Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed astrocytoma-ependymoma
Patients may have prior therapy
18 years of age
Male or Female
Life expectancy is not a consideration for protocol entry
Patients must have normal organ and marrow function as defined below: Leukocytes >3,000/mL, Absolute neutrophil count >1,500/mL, Platelets >100,000/mL, Total bilirubin within normal institutional limits AST (SGOT)/ALT (SGPT)<2.5 X institutional upper limit of normal, Creatinine within normal institutional limits or Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Confirmation of Glial Tumor
Gross total resection is the aim of surgery
Ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign a written informed consent.

You may not qualify if…

Non-Glial tumor i.e. tumor abscess, metastasis, lymphoma, vasculitis
Tumor with perforating vessels
Tumor involves critical fiber tracks
Use of the microsurgical tool monopolar loop
Subject has preexisting severe deficits concerning language or motor function not resolved with steroids
Performance Status of less than 60
Prior therapy is not an exclusion criterion
Patients may not be receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA)
Personal or family history of porphorias
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Where it is running

Legacy Health System — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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