Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme - Full Text View

Purpose

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)

Condition	Intervention	Phase
Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor	Drug: aminolevulinic acid Procedure: therapeutic conventional surgery	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	A Phase 2 Comparative Study of 5-Aminolevulinic Acid (5-ALA) and Intraoperative MRI (iMRI) to Enhance Completeness of Resection of Glioblastoma

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Aminolevulinic acid Aminolevulinic acid hydrochloride

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:

Volume of residual enhancing tumor, as determined by intraoperative volume MRI without and with gadolinium, following maximal resection with use of aminolevulinic acid [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Volume of enhancing tumor (initial and residual) will be determined by use of a softwarebased volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).
Comparison between the volume of resected tissue (defined as the volume of the resection cavity) and the pre-operative enhancing tumor volume [ Time Frame: Up to day 1 ] [ Designated as safety issue: No ]
Volume of enhancing tumor (initial and residual) will be determined by use of a software-based volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).

Secondary Outcome Measures:

Time to disease progression (TTP), determined by review of MRIs performed post operatively as clinically indicated, evaluated with use of the new international criteria proposed by the Response in NeuroOncology (RANO) Committee [ Time Frame: From the date of surgery with aminolevulinic acid to the date of progression, assessed up to 1 year ] [ Designated as safety issue: No ]
Overall survival, by periodic follow up review of the patient charts and by correlation with the Social Security Death Index [ Time Frame: From the date of surgery with aminolevulinic acid to the date of death, assessed up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2012
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Diagnostic (aminolevulinic acid) Patients receive aminolevulinic acid PO 2-4 hours before surgery.	Drug: aminolevulinic acid Given PO Other Names: 5-ALA 5-Aminolaevulinic Acid ALA Procedure: therapeutic conventional surgery Undergo surgery

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575275

Locations

United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Michael A. Vogelbaum, MD, PhD 216-444-8564 vogelbm@ccf.org
Principal Investigator: Michael A. Vogelbaum

Sponsors and Collaborators

Michael Vogelbaum, MD, PhD

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Michael Vogelbaum, MD, PhD

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

More Information

No publications provided

Responsible Party:	Michael Vogelbaum, MD, PhD, Principal Investigator, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT01575275 History of Changes
Other Study ID Numbers:	CASE1311, NCI-2012-00452
Study First Received:	April 9, 2012
Last Updated:	December 5, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Brain Neoplasms
Glioblastoma
Gliosarcoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial

Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Aminolevulinic Acid
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013