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Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme

A Phase 2 Comparative Study of 5-Aminolevulinic Acid (5-ALA) and Intraoperative MRI (iMRI) to Enhance Completeness of Resection of Glioblastoma

NCT01575275•Michael Vogelbaum, MD, PhD

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the safety and performance of an investigational agent, known as 5-ALA or Gliolan (aminolevulinic acid), that many be useful to a surgeon for visualizing a tumor during surgery. It is also being studied to determine if there are differences in what Gliolan shows a surgeon compared to intraoperative magnetic resonance imaging (MRI)

Detailed Description

PRIMARY OBJECTIVES: I. Determine the volume of residual enhancing tumor after a 5-ALA guided resection of a glioblastoma multiforme (GBM). II. Determine the volume of tissue removed compared to the measured enhancing tumor evaluated on a pre-operative MRI. SECONDARY OBJECTIVES: I. Evaluate the time to tumor progression. II. Evaluate the overall survival. OUTLINE: Patients receive aminolevulinic acid orally (PO) 2-4 hours before surgery. After completion of study treatment, patients are followed up for 2 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have a suspected or biopsy proven newly diagnosed GBM, or a recurrent GBM or suspected GBM (in patient with pathologically diagnosed prior World Health Organization \[WHO\] grade II or III tumor) in a patient undergoing a clinically-indicated surgery.
•Age \>= 18 years of age.
•Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
•Life expectancy is not a consideration for protocol entry
•Patients must have normal organ and marrow function as defined below:
•Absolute neutrophil count \>= 1,500/uL
•Platelets \>= 100,000/uL
•Total bilirubin within normal institutional limits
•Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal
•Creatinine within normal institutional limits; OR
+3 more criteria

Exclusion Criteria

•Prior therapy is not an exclusion criterion
•Patients may not be receiving any other investigational agents
•History of allergic reactions attributed to aminolevulinic acid (ALA)
•Current treatment with hypericin (or an extract) or other photosensitizing agents
•Personal or immediate family (parents, siblings, children) history of porphyrias
•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
•Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ALA

Locations (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Key Dates

Start Date

May 1, 2012

Primary Completion Date

May 1, 2014

Completion Date

August 1, 2014

Last Updated

July 31, 2018

Enrollment

ACTUAL participants

Conditions

Adult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaRecurrent Adult Brain Tumor

Interventions

aminolevulinic acid

DRUG

therapeutic conventional surgery

PROCEDURE

Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas

NCT02613988

Adult Glioblastoma

View study

COMPLETEDPHASE2

NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma

NCT01894061

Adult Giant Cell GlioblastomaAdult Glioblastoma+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme

Inclusion Criteria

Exclusion Criteria

Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas

NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma

Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma

Temozolomide and Radiation Therapy With or Without Cediranib Maleate in Treating Patients With Newly Diagnosed Glioblastoma

Dimethyl Fumarate, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma