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

Legacy Health System

Status and phase

Unknown

Phase 2

Conditions

Glioma

Treatments

Drug: 5-Aminolevuline Acid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01403311

5-ALA-01

Details and patient eligibility

About

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

Full description

This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing brain tumors during surgery. When ALA is provided at an increased concentration, protoporphorin concentration in the malignant cell increases and renders the cell fluorescent under long ultraviolet light. This study looks at using oral ALA to help identify the tumor cells intraoperatively and facilitate complete resection.

Oral ALA will be given prior to image-guided microsurgical resection of the tumor. Following tumor resection under light microscopy, the tumor bed will be illuminated and any residual fluorescent tissue in cavity will be surgically removed leading to a more complete resection of tumor. Pathologic confirmation of tumor type will be made by neuropathology. Photosensitizer concentration in malignant and normal tissue will be estimated by fluorescence microscopy.

Enrollment

18 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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