Spots Global Cancer Trial Database for Aminolevulinic Acid During Surgery in Treating Patients With Malignant Brain Tumors

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Trial Identification

Brief Title: Aminolevulinic Acid During Surgery in Treating Patients With Malignant Brain Tumors

Official Title: A Phase 1 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

Study ID: NCT01148966

Conditions

Adult Anaplastic Astrocytoma

Adult Anaplastic Oligodendroglioma

Adult Giant Cell Glioblastoma

Adult Glioblastoma

Adult Gliosarcoma

Adult Mixed Glioma

Recurrent Adult Brain Tumor

Interventions

aminolevulinic acid

laboratory biomarker analysis

therapeutic conventional surgery

Study Description

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

Detailed Description: PRIMARY OBJECTIVES I. Establish a safe dose for oral ALA administration. SECONDARY OBJECTIVES I. Determine which of 3 ALA (aminolevulinic acid) 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. OUTLINE: This is a phase I, dose-escalation study Patients receive aminolevulinic acid orally (PO) 4 hours before undergoing surgery. After completion of study treatment, patients are followed up at week 5 and then every 8-12 weeks for 27 months.