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A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively

Outcome Time Frame:

participants will be followed while in the hospital and for 12 weeks after surgery

Safety Issue:


Principal Investigator

Jefferson Chen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Legacy Health System


United States: Food and Drug Administration

Study ID:




Start Date:

October 2010

Completion Date:

December 2013

Related Keywords:

  • Glioma
  • Anaplastic astrocytoma
  • Astrocytoma
  • Brain stem glioma
  • Ependymoma
  • Glioblastoma
  • Glioblastoma multiforme
  • Gliosarcoma
  • oligodendroglioma
  • Medulloblastoma
  • Mixed astrocytoma-ependymoma
  • ALA
  • Brain Neoplasms
  • Glioma



Legacy Health SystemPortland, Oregon  97210