Status:
COMPLETED
Study of Aminolevulinic Acid to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
Lead Sponsor:
Advocate Hospital System
Conditions:
Brain Tumors
Eligibility:
All Genders
Phase:
PHASE1
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 chi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00671710
Start Date
April 1 2008
End Date
November 1 2010
Last Update
January 14 2011
Active Locations (1)
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1
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068