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

Primary Purpose

Brain Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aminolevulinic Acid
Sponsored by
Advocate Hospital System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Tumors focused on measuring malignant glial brain tumors

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Advocate Lutheran General Hospital

Outcomes

Primary Outcome Measures

Establish safe dose for oral ALA administration. NCI Common Toxicity Criteria will be used to quantify toxicity following ALA administration.

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.

Full Information

First Posted
April 30, 2008
Last Updated
January 13, 2011
Sponsor
Advocate Hospital System
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1. Study Identification

Unique Protocol Identification Number
NCT00671710
Brief Title
Study of Aminolevulinic Acid to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
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 Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Advocate Hospital System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors
Keywords
malignant glial brain tumors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aminolevulinic Acid
Other Intervention Name(s)
ALA
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Ruge, M.D.
Organizational Affiliation
Advocate Lutheran General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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