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RATIONALE: Aminolevulinic acid becomes active when it is exposed to a certain kind of light and may help doctors find and remove tumor cells during surgery.
PRIMARY OBJECTIVES I. Establish a safe dose for oral ALA administration.
SECONDARY OBJECTIVES I. Determine which of 3 ALA doses (10, 20 or 30 mg/kg) provide optimal discrimination between normal and malignant tissue intraoperatively.
II. Determine whether or not the use of ALA (compared to comparable cases performed without the aid of ALA) leads to a higher rate of gross total resection, as determined by postoperative MRI scanning within 48 hour of surgery completion.
III. Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA.
IV. Define PpIX accumulation in malignant and normal brain tissue.
OUTLINE: This a phase I, dose-escalation study followed by a phase II study.
Patients receive oral aminolevulinic acid 4 hours prior to undergoing surgery. After completion of study treatment, patients are followed at week 5 and then every 8-12 weeks for 27 months.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adult Anaplastic Astrocytoma
aminolevulinic acid, laboratory biomarker analysis, therapeutic conventional surgery
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Not yet recruiting
Fred Hutchinson Cancer Research Center
Published on BioPortfolio: 2014-08-27T03:12:43-0400
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A compound produced from succinyl-CoA and GLYCINE as an intermediate in heme synthesis. It is used as a PHOTOCHEMOTHERAPY for actinic KERATOSIS.
An enzyme that catalyzes the formation of porphobilinogen from two molecules of 5-aminolevulinic acid. EC 188.8.131.52.
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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