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Status unknownNCT01403311ALAUpdated Mar 26, 2014

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

A Phase 2 interventional study of 5-Aminolevuline Acid in Glioma, sponsored by Legacy Health System. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-26.

Sponsored by Legacy Health System · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Glioma

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Keywords

  • Anaplastic astrocytoma
  • Astrocytoma
  • Brain stem glioma
  • Ependymoma
  • Glioblastoma
  • Glioblastoma multiforme
  • Gliosarcoma
  • oligodendroglioma
  • Medulloblastoma
  • Mixed astrocytoma-ependymoma
  • ALA
03

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's planned enrollment of 18 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Legacy Health System is the lead sponsor of 30 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    ALA

    5-Aminolevuline Acid (ALA)

    Drug: 5-Aminolevuline Acid

Interventions

  • Drug5-Aminolevuline Acid

    5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before surgery

06

What researchers measure

Primary outcomes

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

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

Secondary outcomes

  1. Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA

    Time frame: participants will be followed for 24 months

07

Study locations

1 site
  • Legacy Health System
    Portland, Oregon 97210, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01403311
Lead sponsor
Legacy Health System
Collaborators
DUSA Pharmaceuticals, Inc.
Responsible party
Jefferson W Chen, MD (Principal Investigator, Legacy Health System) — Principal investigator
First posted
Jul 27, 2011
Start date
Oct 2010
Primary completion
Dec 2011
Completion
Mar 2015 (estimated)
Last update
Mar 26, 2014

Study contacts

Jefferson Chen, MD, PhD
principal investigator · Legacy Health System
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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