Aminolevulinic Acid During Surgery in Treating Patients With Malignant Brain Tumors
| Status: | Archived |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | January 2011 |
A Phase 1 and 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
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.
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 is 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.
We found this trial at
1
site
1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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