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Treatment Name: A Phase 1 and 2 Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
Keywords: 5-Aminolevulinic Acid, 5-ALA
Phase: Phase 1/2
Treatment ID#s: VT2036         NCT01128218
Age Group: Adults Only
Min Karnofsky Score: 50: Requires considerable assistance and frequent medical care
Conditions: Newly Diagnosed: Y
Recurrent: Y
Prior Surgery is Allowed
Prior Radiation is Allowed
Prior Chemotherapy is Allowed
Recent studies in Germany have confirmed the utility of pre-operative oral 5-ALA and intraoperative brain tumor fluorescence in aiding the resection of malignant brain tumors. These studies have led to the approval of oral 5-ALA for this indication by the European Medicines Agency, but it has not been approved for this indication by the United States FDA. This proposal is a phase 1 and phase 2 trial that will hopefully lead to FDA approval of oral 5-ALA for intra-operative visualization of malignant brain tumors.
Last Updated: 02/26/2012
Tumor Types: Anaplastic Astrocytoma
Glioblastoma Multiforme
Mixed Glioma
Oligodendroglioma High Grade
PNET Tumor
Comments: In the phase 1 part of this proposed study, a minimum of 3 to a maximum of 18 patients will be administered oral 5-ALA 2-3 hours prior to surgery in cohorts of 3 at five escalating doses of 5-ALA (10, 20, 30, 40, or 50 mg/kg). The following data will be collected: • Dose-limiting toxicity data • Tumor fluorescence assessed by neurosurgeon (0 to +++) in three distinct areas of fluorescence (Strong fluorescence, Weak fluorescence, No fluorescence) • Tumor density from biopsies obtained by the neurosurgeon in the same three distinct areas of fluorescence and assessed by neuropathology (Solid tumor, Tumor mixed infiltrating normal brain, No tumor) • Neurosurgeon’s intra-operative estimate of residual tumor • Neuroradiologist’s estimate of post-operative residual tumor on MRI This trial will evaluate: • The toxicity of a single dose of oral 5-ALA given pre-operatively. • The sensitivity and specificity of 5-ALA - Protoporphyrin IX (Pp IX) as an intraoperative fluorescent detection agent and aid for resection of tumor tissue remaining in the walls of the resection cavity of primary and recurrent malignant brain tumors. • The relationship of the neurosurgeon’s estimate of the extent of malignant glioma resection (as guided by tumor fluorescence) to the actual extent of resection determined by post-operative imaging. Following completion of the phase 1 portion of this trial, an additional 15 subjects will be entered at the recommended phase 2 dose level in order to further define the above parameters at the recommended phase 2 dose level.
Treatment Type: Surgery.
Contact: Southern Illinois University School of Medicine
Jeffrey Cozzens, MD
Professor and Chair, Neurosurgery
Division of Neurosurgery
PO Box 19680
Springfield, IL 62794-9680
Fax: 217-5458103
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