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Aminolevulinic Acid During Surgery in Treating Patients With Malignant Brain Tumors

2014-08-27 03:12:43 | BioPortfolio

Summary

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.

PURPOSE: This phase I/II trial is studying the side effects and best dose of aminolevulinic acid during surgery in treating patients with malignant brain tumors.

Description

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Adult Anaplastic Astrocytoma

Intervention

aminolevulinic acid, laboratory biomarker analysis, therapeutic conventional surgery

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle
Washington
United States
19024-1024

Status

Not yet recruiting

Source

Fred Hutchinson Cancer Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:43-0400

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