5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor

NCT02632370 | Completed DMC FDA Drug

• 3 other identifiers: GCO 15-2034-0001CGH932015PRMC 15-085
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 17

Brief Summary

In support of the US marketing application for 5-ALA, this single arm trial is being conducted to establish the efficacy and safety of Gliolan® (5-ALA) in patients with newly diagnosed or recurrent malignant gliomas. The hypothesis of the study is Gliolan® (5-ALA), as an adjunct to tumor resection, is safe and that real-time tissue fluorescence correlates with malignant histopathology. The primary objective in this single arm study is to define the positive predictive value (PPV) of Gliolan®-induced PPIX fluorescence for malignant tumor at the time of initial resection and first use of FGS by taking a biopsy of tissue presenting with red fluorescence when observed during the course of resection of new or recurrent malignant gliomas. The functionality and performance reliability of the blue light excitation microscope platforms will be assessed.

Conditions

Malignant Gliomas

Keywords

Malignant Gliomas; 5-ALA; tumor resection; malignant tumor

Outcome Measures

Primary Outcomes (1)

• Incidence of diagnostic tissue presence

  Pathologic confirmation of tumor type will be made by a pathologist who will not be informed of the fluorescence status of the tissue samples.

  6 weeks

Secondary Outcomes (4)

• Presence of malignant glioma tumor cells

  6 weeks

• WHO tumor type with grading

  6 weeks

• Ki-67 proliferation index

  6 weeks

• Karnofsky Performance Scale

  6 weeks

Study Arms (1)

Gliolan®

Gliolan® is presented as a powder for oral solution in 60 ml colorless glass vials. The formulation contains 1.5 g 5-aminolevulinic acid hydrochloride corresponding to 1.17 g of 5-aminolevulinic acid. The oral solution is intended for single (partial) use.

Drug: Gliolan®; Procedure: Fluorescence-Guided Surgery

Interventions

Gliolan® DRUG

single dose of oral 5-ALA (20mg/kg bodyweight) at 3 hours (range 2-5 hours) given preoperatively

Also known as: 5-ALA

Gliolan®

Fluorescence-Guided Surgery PROCEDURE

performed utilizing blue light. At least 3-5 fluorescent tissue samples will be taken.

Also known as: FGS

Gliolan®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with new or recurrent malignant gliomas

You may qualify if:

• Subjects included must have an MRI documenting a primary brain tumor for which resection is indicated and has been planned. These patients will include those with newly diagnosed or recurrent malignant gliomas. Standard criteria for diagnosis will include a distinct ring-like pattern of contrast enhancement with thick irregular walls on MRI for patients with a presumed newly diagnosed malignant glioma.
• Age 18-80.
• Karnofsky\>60%.
• Subjects must have normal organ and marrow function as defined below:
• Leukocytes \>3,000/mL Platelets \>100,000/mL Total bilirubin below upper limit of normal AST (SGOT)/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 patients with creatinine levels above institutional normal.

You may not qualify if:

• Ability to understand and the willingness to sign a written informed consent document. Translation will be provided as appropriate by institution.
• Patients with radiographic tumors of, or involving, nonresectable midline, the basal ganglia, or brain stem as assessed by MRI.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA). Patients should refrain from use of other potential phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) for 72 h.
• Personal or family history of porphyria.
• 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. . Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 5-aminolevulinic acid (5-ALA), breastfeeding should be discontinued if the mother is treated with 5-aminolevulinic acid (5-ALA).
• Women who are pregnant will be excluded from the trial as aminolevulinic acid (ALA) is unknown to be teratogenic or have abortifacient effects Prior history of GI perforation, diverticulitis, and/or peptic ulcer disease.

Sponsors & Collaborators

• Constantinos Hadjipanayis: lead
• Massachusetts General Hospital: collaborator

Study Sites (17)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

CentraCare St. Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

St. Luke's Marion Bloch Neuroscience Institute

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of New Mexico School of Medicine, Department of Neurosurgery

Albuquerque, New Mexico, 87131, United States

Location

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Penn State- Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, tumor samples

MeSH Terms

Conditions

Glioma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Bob Carter, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 16, 2015
• Study Start: May 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

US (17)