A Study to Evaluate Gleolan to Enhance Tumor Visualization in Patients with Newly-diagnosed or Recurrent Meningioma

Overview

About this study

The purpose of this study is to investigate  the safety, diagnostic performance, and clinical  usefulness of  the imaging  agent Gleolan™ (Aminolevulinic  Acid Hydrochloride, ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of meningiomas during tumor resection surgery. ALA is a prodrug that is metabolized  intracellularly  to  form  the  fluorescent  molecule  Protoporphyrin  IX  (PpIX). 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • A pre-operative MRI ≤ 90 days of study enrollment documenting a suspected meningioma or suspected recurrence of a meningioma for which a complete meningioma resection is indicated and has been planned.
  • Adult age ≥ 18 years.
  • Patient must have normal organ and bone marrow function and be appropriate surgical candidates per site SOC.
  • Patient must have recording of each parameter as defined below:
    • Bilirubin Below upper limit of normal;
    • AST (SGOT) < 2.5 X institutional upper limit of normal;
    • ALT (SGPT) < 2.5 X institutional upper limit of normal;
    • Creatinine Below upper limit of normal OR Creatinine clearance >60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal.
  • The patient must demonstrate the ability to understand the informed consent document and the willingness and ability to sign a written informed consent document. The study consent documents will be prepared in English and German and Spanish. Translation for non-English, non-German, or non-Spanish speaking participants will be provided as appropriate by institution, as required.
  • WOCBP and men participating must agree to use highly effective forms of contraception, and men must also agree not to donate sperm for the duration of treatment, and for at least 42 days after the one time use of the study drug.

Exclusion Criteria:

  • History of allergic reactions attributed to compounds of similar chemical/biologic composition to Gleolan.
  • Known or documented personal or family history of porphyria.
  • Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness.
  • Patient has had a meningioma resection or radiation treatment within 90 days prior to informed consent.
  • Social or medical situations that would limit compliance with study requirements (e.g., ability to travel for follow-up or inability to obtain appropriate pre-op MRI (e.g.,cardiac pacemaker).
  • Women who are pregnant or plan to become pregnant during study participation.
  • Prior history of gastrointestinal perforation, diverticulitis, and or/peptic ulcer disease.
  • Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment or within 5 plasma half-life of the preceding study drug, whatever is longer.
  • Simultaneous use of other potentially phototoxic substances (St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period (see MOPS for detailed list).
  • Unwillingness by patient to sign consent or return for subsequent visits following surgery.
  • Any condition that in the opinion of the Investigator would exclude the patient as a viable candidate for this study.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jamie VanGompel, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

RST Neurologic Surgery Research Team

(507) 293-1963

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Bernard Bendok, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Rachel Kendrick

Kendrick.Rachel@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20509118

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