Study of Aminolevulinic Acid to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00671710
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : January 14, 2011
Information provided by:
Advocate Hospital System

Brief Summary:
Tumors of the central nervous system are potentially curable. For tumors of comparable histology and grade, resectability is the most important prognostic factor affecting survival particularly in children. However, the infiltrative nature of the malignant cells produces indistinct borders between normal and malignant tissues, and the lack of easily identifiable tumor margins confounds attempts toward total resection. The investigators propose to identify the borders of tumors intraoperatively using protoporphyrin fluorescence of the malignant cells and thereby provide more complete tumor resection.

Condition or disease Intervention/treatment Phase
Brain Tumors Drug: Aminolevulinic Acid Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 1 and 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
Study Start Date : April 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Intervention Details:
  • Drug: Aminolevulinic Acid
    Escalating doses (10mg/kg, 20mg/kg, 30mg/kg) of Aminolevulinic Acid administered orally 3 hours prior to surgery to enhance visualization of malignant brain tumor.
    Other Name: ALA

Primary Outcome Measures :
  1. Establish safe dose for oral ALA administration. NCI Common Toxicity Criteria will be used to quantify toxicity following ALA administration. [ Time Frame: 108 weeks ]

Secondary Outcome Measures :
  1. Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA. Kaplan-Meier plots of survival and TTP will be generated for all study subjects and for patients at the 30 mg/kg dose level alone. [ Time Frame: 108 weeks ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients must have clinically documented primary brain tumor for which resection is clinically indicated. Anticipated histology at resection should include:anaplastic astrocytoma, astrocytoma malignant NOS,brain stem glioma, ependymoma malignant, glioblastoma, glioblastoma multiforme, gliosarcoma, malignant oligodendroglioma, medulloblastoma, mixed astrocytoma-ependymoma
  • prior therapy is not a consideration in protocol entry
  • age unrestricted
  • ECOG performance status<2(Karnofsky>60%,)
  • 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
  • women of child-bearing potential and men must agree to use adequate contraception(hormonal or barrier method of birth control;abstinence) prior to study entry and for the duration of study participation.
  • 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:

  • 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 adic (ALA)
  • personal or family history of porphyrias
  • 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
  • pregnant women are excluded, breastfeeding should be discontinued if mother is treated with aminolevulinic acid.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00671710

United States, Illinois
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Sponsors and Collaborators
Advocate Hospital System
Principal Investigator: John Ruge, M.D. Advocate Lutheran General Hospital

Responsible Party: John Ruge, M.D., Advocate Lutheran General Hospital Identifier: NCT00671710     History of Changes
Other Study ID Numbers: 4079
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: January 14, 2011
Last Verified: June 2010

Keywords provided by Advocate Hospital System:
malignant glial brain tumors

Additional relevant MeSH terms:
Aminolevulinic Acid
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Photosensitizing Agents
Dermatologic Agents