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

Study 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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01575275
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Michael Vogelbaum, MD, PhD
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Michael Vogelbaum, MD, PhD
Principal Investigator Affiliation Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
Additional Details

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.

Arms & Interventions

Arms

Experimental: Diagnostic (aminolevulinic acid)

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

Interventions

Drug: - aminolevulinic acid

Given PO

Procedure: - therapeutic conventional surgery

Undergo surgery

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland, Ohio

Status

Address

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195

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