Details For Selected Brain Tumor Treatment

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ID is our internal ID - starting with VT.
Min Karnofsky is a general guide to how well you have to function to use this treatment
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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 Gliosarcoma 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 Phone:217-545-8863 Fax: 217-5458103 Click here to send an email Website: www.siumed.edu/surgery/neurosurgery/