Status:
UNKNOWN
A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
Lead Sponsor:
Legacy Health System
Collaborating Sponsors:
DUSA Pharmaceuticals, Inc.
Conditions:
Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.
Detailed Description
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing brain tumors during surgery. When ALA is provided at an increased concentration, protoporphorin con...
Eligibility Criteria
Inclusion
- Patients must have clinically documented primary brain tumor for which resection is clinically indicated. The anticipated histology at resection should include: Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed astrocytoma-ependymoma
- Patients may have prior therapy
- 18 years of age
- Male or Female
- 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
- Confirmation of Glial Tumor
- Gross total resection is the aim of surgery
- 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
- Non-Glial tumor i.e. tumor abscess, metastasis, lymphoma, vasculitis
- Tumor with perforating vessels
- Tumor involves critical fiber tracks
- Use of the microsurgical tool monopolar loop
- Subject has preexisting severe deficits concerning language or motor function not resolved with steroids
- Performance Status of less than 60
- 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 acid (ALA)
- Personal or family history of porphorias
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2015
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01403311
Start Date
October 1 2010
End Date
March 1 2015
Last Update
March 26 2014
Active Locations (1)
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1
Legacy Health System
Portland, Oregon, United States, 97210