A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors

Phase 2

Terminated

• Conditions: Glioma; Glioblastoma; Glioblastoma Multiforme; Malignant Glioma; Astrocytoma
• Interventions: Drug: Aminolevulinic Acid

• Registration Number: NCT01351519
• Lead Sponsor: MultiCare Health System Research Institute

Brief Summary

In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue improves the surgeon's ability to completely resect or remove the brain tumor.

Detailed Description

This is a Phase 2 study and all subjects will receive open label Aminolevulinic Acid in a dose of 20mg/kg given orally 3 hours prior to surgery. Brain tumors will be resected with the aid of ultraviolet light to visualize the tumor. After surgery an MRI will be done to determine whether the tumor has been completely or partially resected. All subjects will be followed for safety. All subjects will be followed closely by clinical examination and by MRI to monitor for disease recurrence.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-07
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-11
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Clinically documented primary brain tumor for which surgical resection is indicated.
• Age 18 years and older.
• ECOG Performance status less than or equal to 2.
• Laboratory values as follows:

Leukocytes greater than or equal to 3,000. ANC greater than or equal to 1,500. Platelets greater than or equal to 100,000. Total Bilirubin WNL. AST/ALT less than or equal to 2.5 times ULN. Creatinine WNL. or Creatinine Clearance greater than or equal to 60ml/min/1.73m2 if SCr above institutional normal.

-Ability to provide informed consent or consent from a Legally Authorized Representative.

Exclusion Criteria

• Receipt of an investigational agent within 30 days.
• Allergy to ALA or similar compounds.
• Personal or family history of porphyria.
• Uncontrolled intercurrent illness.
• Inability to comply with the protocol.
• Pregnancy, breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aminolevulinic Acid (AL)	Aminolevulinic Acid	-

Primary Outcome Measures

Name	Time	Method
Complete Resection	Day 2	Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls
Time to disease progression after initial surgery.	Up to 2 years	Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to three years	Determine the overall survival compared to historical controls.
Determine the number of subjects with adverse events due to ALA in this dosage and indication.	Through 45 days	Subjects will be followed closely for adverse events including biochemical abnormalities through laboratory monitoring and for clinically evident adverse events including possible skin reactions that may occur.

Trial Locations

Locations (1)

MultiCare Health System Research Institute; 🇺🇸 Tacoma, Washington, United States