Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma

NCT04305470 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: NXDC-MEN-301
• Study Type: interventional
• Target: 108
• Locations: 3 countries
• Sites: 17

Brief Summary

This Phase 3 open-label single-arm study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real time detection and visualization of meningiomas during tumor resection surgery. The study is planned to run for 15 months with individual study participation lasting for approximately 2 months.

Conditions

Meningioma

Keywords

ALA; fluorescence guided surgery; Gleolan; meningioma

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants Who Had at Least 1 Indeterminate Tissue or Unexpected Fluorescent End of Surgery (EOS) Tissue Where Gleolan-induced PpIX Fluorescence Status is Consistent With Histology (i.e., True Positive or True Negative for Meningioma).

  Responders are defined as the percentage of participants among all participants receiving Gleolan (the Intent to Image Population) who had at least one indeterminate tissue or unexpected fluorescent end of surgery (EOS) tissue where Gleolan-induced PpIX fluorescence status was consistent with central laboratory histology. For a participant to be considered a success, only biopsies considered 'non-obvious' for tumor status by an external panel of neurosurgeons who reviewed videos and images were eligible to be assessed in the numerator. A two-sided 95% confidence interval was calculated using the Wilson (score) method. The lower bound of the confidence interval was tested against a null hypothesis value of 30%. A modified worst-case imputation was used for missing data.

  Surgery (Day 1)

Secondary Outcomes (3)

• Positive Predicted Value (PPV) of Gleolan-induced PpIX Fluorescence Status of Biopsied Tissue Locations at the Margin of the Tumor [Indeterminate Tissues and Unexpected Fluorescent EOS Tissues (Combined)].

  Surgery (Day 1)

• Negative Predicted Value (NPV) of Gleolan-induced PpIX Fluorescence Status of Biopsied Tissue Locations at the Margin of the Tumor [Indeterminate Tissues].

  Surgery (Day 1)

• Positive Predictive Value of Single Bulk Tumor Sample Obtained From Each Participant.

  Surgery (Day 1)

Study Arms (1)

Single Arm

EXPERIMENTAL

Open-label, intra-subject control

Drug: Gleolan

Interventions

Gleolan DRUG

One time oral dose on day of surgery (20 mg/kg bodyweight)

Also known as: Aminolevulinic Acid Hydrochloride / ALA / ALA HCI

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A pre-operative MRI within ≤ 90 days of study enrollment documenting a suspected meningioma or suspected recurrence of a meningioma for which a 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 m2 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.

You may not qualify if:

• 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 of 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 within 90 days of informed consent.
• 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.

Sponsors & Collaborators

• NX Development Corp: lead

Study Sites (17)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

Providence St. Joseph Hospital

Orange, California, 92868, United States

Location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

University of Miami

Coral Gables, Florida, 33136, United States

Location

Baptist Health South Florida

Miami, Florida, 33176, United States

Location

Southern Illinois University

Springfield, Illinois, 62702, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

NYU Langone Health

Brooklyn, New York, 11220, United States

Location

University of Pennsylvania- Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

University Hospital Münster

Münster, Germany

Location

Related Publications (1)

• Stummer W, Holling M, Bendok BR, Vogelbaum MA, Cox A, Renfrow SL, Widhalm G, Ezrin A, DeSena S, Sackman ML, Wyse JW. The NXDC-MEN-301 Study on 5-ALA for Meningiomas Surgery: An Innovative Study Design for the Assessing the Benefit of Intra-Operative Fluorescence Imaging. Brain Sci. 2022 Aug 6;12(8):1044. doi: 10.3390/brainsci12081044.

  PMID: 36009108 RESULT

MeSH Terms

Conditions

Meningioma

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Michael Giammona, Senior Director, Clinical Operations
• Organization: NX Development Corporation

mgiammona@nxdevcorp.com

512-348-3885

Study Officials

• Walter Stummer, MD

  Universitätsklinikum Münster

  PRINCIPAL INVESTIGATOR

• Bernard Bendok, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 3, open-label, single arm study.

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 12, 2020
• Study Start: October 28, 2020
• Primary Completion: November 7, 2022
• Study Completion: December 13, 2022
• Last Updated: May 18, 2026
• Results First Posted: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); US (15); AU (1)