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

This study has been completed.
Sponsor:
Information provided by:
Advocate Hospital System
ClinicalTrials.gov Identifier:
NCT00671710
First received: April 30, 2008
Last updated: January 13, 2011
Last verified: June 2010
  Purpose

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 Intervention Phase
Brain Tumors
Drug: Aminolevulinic Acid
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Advocate Hospital System:

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

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: April 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671710

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

No publications provided

Responsible Party: John Ruge, M.D., Advocate Lutheran General Hospital
ClinicalTrials.gov Identifier: NCT00671710     History of Changes
Other Study ID Numbers: 4079
Study First Received: April 30, 2008
Last Updated: January 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Advocate Hospital System:
malignant glial brain tumors

Additional relevant MeSH terms:
Neoplasms
Brain Neoplasms
Glioma
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
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 30, 2014