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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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One of several acid phosphatases in humans, other mammals, plants, and a few prokaryotes. The protein fold of tartrate-resistant acid phosphatase (TRAP) resembles that of the catalytic domain of plant purple acid phosphatase and other serine/threonine-protein phosphatases that also contain a metallophosphoesterase domain. One gene produces the various forms which include purple acid phosphatases from spleen and other tissues. Tartrate-resistant acid phosphatase is a biomarker for pathological states in which it is over-expressed. Such conditions include GAUCHER DISEASE; HODGKIN DISEASE; BONE RESORPTION; and NEOPLASM METASTASIS.
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An enzyme that catalyzes the formation of porphobilinogen from two molecules of 5-aminolevulinic acid. EC 188.8.131.52.
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