A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain (ALA)

A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.

Study Overview

• Status: Unknown
• Conditions: Glioma
• Intervention / Treatment: Drug: 5-Aminolevuline Acid

Detailed Description

This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing brain tumors during surgery. When ALA is provided at an increased concentration, protoporphorin concentration in the malignant cell increases and renders the cell fluorescent under long ultraviolet light. This study looks at using oral ALA to help identify the tumor cells intraoperatively and facilitate complete resection.

Oral ALA will be given prior to image-guided microsurgical resection of the tumor. Following tumor resection under light microscopy, the tumor bed will be illuminated and any residual fluorescent tissue in cavity will be surgically removed leading to a more complete resection of tumor. Pathologic confirmation of tumor type will be made by neuropathology. Photosensitizer concentration in malignant and normal tissue will be estimated by fluorescence microscopy.

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97210
      • Legacy Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must have clinically documented primary brain tumor for which resection is clinically indicated. The anticipated histology at resection should include: Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed astrocytoma-ependymoma
• Patients may have prior therapy
• 18 years of age
• Male or Female
• Life expectancy is not a consideration for protocol entry
• Patients must have normal organ and marrow function as defined below: Leukocytes >3,000/mL, Absolute neutrophil count >1,500/mL, Platelets >100,000/mL, Total bilirubin within normal institutional limits AST (SGOT)/ALT (SGPT)<2.5 X institutional upper limit of normal, Creatinine within normal institutional limits or Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
• Confirmation of Glial Tumor
• Gross total resection is the aim of surgery
• Ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

• Non-Glial tumor i.e. tumor abscess, metastasis, lymphoma, vasculitis
• Tumor with perforating vessels
• Tumor involves critical fiber tracks
• Use of the microsurgical tool monopolar loop
• Subject has preexisting severe deficits concerning language or motor function not resolved with steroids
• Performance Status of less than 60
• Prior therapy is not an exclusion criterion
• Patients may not be receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA)
• Personal or family history of porphorias
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALA; 5-Aminolevuline Acid (ALA)	Drug: 5-Aminolevuline Acid; 5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively	participants will be followed while in the hospital and for 12 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA	participants will be followed for 24 months

Collaborators and Investigators

• Sponsor: Legacy Health System
• Collaborators: DUSA Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Jefferson Chen, MD, PhD, Legacy Health System

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimate): July 27, 2011

Study Record Updates

• Last Update Posted (Estimate): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 24, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Anaplastic astrocytoma; Gliosarcoma; Medulloblastoma; Ependymoma; Glioblastoma; Glioblastoma multiforme; Astrocytoma; oligodendroglioma; Brain stem glioma; ALA; Mixed astrocytoma-ependymoma
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 5-ALA-01