Status:
TERMINATED
Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Astrocytoma
Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This research is being done to study the safety and utility of 5-aminolevulinic acid (5-ALA) (also known as Gliolan) for identifying brain tumor tissue during surgery. The goal of this study is to det...
Eligibility Criteria
Inclusion
- Patients must have clinically documented primary brain tumor for which resection is clinically indicated. Radiographic findings should be consistent with high grade glioma. Intraoperative frozen section should either be: anaplastic astrocytoma (WHO Grade III astrocytoma) or glioblastoma (WHO Grade IV astrocytoma).
- Patients must be aged greater than 18 years old
- Karnofsky Performance Score \> 70 (Appendix)
- Patients must have normal organ and marrow function as defined below:
- Leukocytes \> 3,000 /uL
- Absolute neutrophil count \> 1,500/uL
- Platelets \> 100,000/uL
- Total bilirubin within normal institutional limits
- AST/ALT within normal institutional limits
- Creatinine within normal institutional limits
Exclusion
- Prior craniotomy for resection, deep seated tumors in thalamus and brain stem.
- History of allergic reactions to compounds of similar chemical composition to ALA.
- Personal or family history of porphyrias
- Personal history of hepatitis or other liver diseases.
- Pregnant women are excluded from this study because ALA is of unknown teratogenic effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ALA, breastfeeding should be discontinued prior to treatment with ALA.
- Inability to undergo magnetic resonance imaging (i.e. those patients with AICD/pacemakers).
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01502605
Start Date
September 1 2012
End Date
June 1 2016
Last Update
January 5 2017
Active Locations (2)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287