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Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma (MEN-301)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04305470
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
NX Development Corp

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.

Condition or disease Intervention/treatment Phase
Meningioma Drug: Gleolan (Aminolevulinic Acid Hydrochloride/ALA/ALA-HCI) Phase 3

Detailed Description:

This Phase 3 open-label single-arm study is designed 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). The exogenous application of ALA leads to a highly selective accumulation of PpIX in tumor cells. Following excitation with blue light (BL) (λ = 375 - 440 nm), the PpIX, which has accumulated selectively in tumor tissue, emits a red-violet light. This phenomenon allows for the real-time visualization of tumor tissue during resection surgery.

Patients about to undergo resection for suspected meningioma [World Health Organization (WHO) Grade I, II, III] will be screened and informed consent will be obtained prior to surgery and prior to study participation. Eligible study participants will receive an oral solution of Gleolan (20 mg/kg body weight) 3 hours, (target range 2-4 hours) prior to anesthesia, and then undergo surgery for meningioma resection. During the surgery, the surgeon will use a microscope equipped with WL and BL for visualization of Gleolan-induced PpIX fluorescence for the selection of protocol-driven tissue locations and to assess fluorescence status.

Study participants will be evaluated within 48 hours post procedure, 2 weeks post procedure, and 6 weeks post procedure for study safety assessment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase 3, open-label, single arm study.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 3 Multicenter Study of Gleolan (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Newly Diagnosed or Recurrent Meningiomas
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021


Arm Intervention/treatment
Experimental: Single Arm
Open-label, single-arm
Drug: Gleolan (Aminolevulinic Acid Hydrochloride/ALA/ALA-HCI)
One time oral dose on day of surgery (20 mg/kg bodyweight)




Primary Outcome Measures :
  1. The proportion of participants who have at least one indeterminate tissue or unexpected fluorescent End of Surgery (EOS) tissue where Gleolan-induced PpIX fluorescence status is consistent with histology. [ Time Frame: Surgery (Day 1) ]
    Per Protocol Population


Secondary Outcome Measures :
  1. Positive Predicted Value (PPV) of Gleolan-induced PpIX fluorescence of the single bulk tumor tissue obtained from each study participant [ Time Frame: Surgery (Day 1) ]
    Per Protocol Population

  2. Diagnostic accuracy of Gleolan-induced PpIX fluorescence among indeterminate tissue and unexpected fluorescent EOS tissue locations is at least 20% greater than the diagnostic accuracy of the surgeons' assessment. [ Time Frame: Surgery (Day 1) ]
    Biopsy Efficacy Analysis Population

  3. Diagnostic performance of Gleolan-induced PpIX fluorescence will be computed for indeterminate tissue biopsies, unexpected fluorescent EOS tissue biopsies. [ Time Frame: Surgery (Day 1) ]
    Biopsy Efficacy Analysis Population

  4. The concordance between the Surgeon and Adjudication Panel assessment of white light (WL) visualization visualization to identify tissue as likely or unlikely to be meningioma among indeterminate tissues. [ Time Frame: Surgery (Day 1) ]
    Biopsy Efficacy Analysis Population

  5. The concordance between the Surgeon and Adjudication Panel assessment of blue light (BL) visualization to identify fluorescence status of indeterminate tissues. [ Time Frame: Surgery (Day 1) ]
    Biopsy Efficacy Analysis Population



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A pre-operative MRI within ≥ 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.
  2. Adult age ≥ 18 years.
  3. Patient must have normal organ and bone marrow function and be appropriate surgical candidates per site SOC.
  4. 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

  5. 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.
  6. 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:

  1. History of allergic reactions attributed to compounds of similar chemical/biologic composition to Gleolan.
  2. Known or documented personal or family history of porphyria.
  3. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness.
  4. Patient has had a meningioma resection or radiation treatment within 90 days of informed consent.
  5. 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).
  6. Women who are pregnant or plan to become pregnant during study participation.
  7. Prior history of gastrointestinal perforation, diverticulitis, and or/peptic ulcer disease.
  8. 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.
  9. 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).
  10. Unwillingness by patient to sign consent or return for subsequent visits following surgery.
  11. Any condition that in the opinion of the Investigator would exclude the patient as a viable candidate for this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04305470


Contacts
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Contact: Sara Renfrow 859-967-8136 srenfrow@nxdevcorp.com
Contact: Ashley Cox 502-316-8981 acox@nxdevcorp.com

Locations
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United States, Arizona
Mayo Clinic Not yet recruiting
Phoenix, Arizona, United States, 85054
Contact: Bernard Bendok, MD         
United States, California
Keck Hospital of USC Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Trey Garrett       normanga@usc.edu   
Principal Investigator: Gabriel Zada, MD         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Bob Carter, MD         
Principal Investigator: Bob Carter, MD         
United States, Michigan
Henry Ford Health System Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Adam Robin, MD         
United States, New York
NYU Langone Health Not yet recruiting
Brooklyn, New York, United States, 11220
Contact: Thomsas Chen         
Principal Investigator: John Golfinos, MD         
Sub-Investigator: Daniel Orringer, MD         
United States, Pennsylvania
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Benita Valappil         
Principal Investigator: Paul Gardner, MD         
Sub-Investigator: Georgios Zenonos, MD         
United States, Texas
MD Anderson Not yet recruiting
Houston, Texas, United States, 77030
Contact: Summer Stovall         
Principal Investigator: Shaan Raza, MD         
Sub-Investigator: Jeffrey Weinberg, MD         
Austria
Medical University of Vienna Not yet recruiting
Vienna, Austria, 1090
Contact: Georg Widhalm, MD         
Principal Investigator: Georg Widhalm, MD         
Germany
University Hospital Münster Recruiting
Münster, Germany
Contact: Walter Stummer, MD         
Sponsors and Collaborators
NX Development Corp
Investigators
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Study Director: Joe Wyse, PhD NX Development Corp
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Responsible Party: NX Development Corp
ClinicalTrials.gov Identifier: NCT04305470    
Other Study ID Numbers: NXDC-MEN-301
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NX Development Corp:
ALA
fluorescence guided surgery
Gleolan
meningioma
Additional relevant MeSH terms:
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Meningioma
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
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents