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

NCT ID: NCT01575275

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-08-31

Brief 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.

Conditions

Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (aminolevulinic acid)

Patients receive aminolevulinic acid PO 2-4 hours before surgery.

Group Type: EXPERIMENTAL

aminolevulinic acid

Intervention Type: DRUG

Given PO

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo surgery

Interventions

aminolevulinic acid

Given PO

Intervention Type: DRUG

therapeutic conventional surgery

Undergo surgery

Intervention Type: PROCEDURE

Other Intervention Names

5-ALA; 5-Aminolaevulinic Acid; ALA

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Michael Vogelbaum, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Michael Vogelbaum, MD, PhD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Vogelbaum, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

NCI-2012-00452

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE1311

Identifier Type: -

Identifier Source: org_study_id