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

NCT ID: NCT00671710

Last Updated: 2011-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-11-30

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.

Conditions

Brain Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

ALA

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advocate Hospital System

OTHER

Sponsor Role: lead

Responsible Party

Advocate Lutheran General Hospital

Principal Investigators

John Ruge, M.D.

Role: PRINCIPAL_INVESTIGATOR

Advocate Lutheran General Hospital

Locations

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Countries

United States

Other Identifiers

4079

Identifier Type: -

Identifier Source: org_study_id