Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain

NCT01116661 | Terminated Phase 2 Results DMC

• 1 other identifier: 10101
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

The prodrug, 5-Aminolevulinic acid (ALA), has been shown to lead to intracellular accumulation of fluorescent porphyrins in high grade malignant gliomas in the brain. On imaging, this accumulation of fluorescent porphyrins helps delineate tumor borders, resulting in the surgeon being better able to visualize and thus able to make a complete, or near-complete resection of the tumor.

Conditions

Glioma

Keywords

glioma; high grade glioma, low grade glioma

Outcome Measures

Primary Outcomes (1)

• The Percentage of Biopsies Taken From the Most Fluorescent Tissues That Have Tumorous Content.

  Biopsies were examined by a pathologist to determine the amount of tumor content from the most fluorescent tissues

  1 day

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  14 days

Study Arms (1)

ALA for glioma (WHO G1-IV) subjects

EXPERIMENTAL

Up to 300 patients with diagnosed glioma (WHO G1-IV) eligible for surgery will be entered into the trial and will be given 5-Aminolevulinic Acid (ALA) orally at a dose of 20mg/kg body weight preoperatively

Drug: 5-Aminolevuline Acid (ALA)

Interventions

5-Aminolevuline Acid (ALA) DRUG

Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery

ALA for glioma (WHO G1-IV) subjects

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presumptive diagnosis of high grade or low grade glioma based on imaging studies, or will have recurrent high-grade or low grade gliomas that have previously undergone diagnosis (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme). Both of these groups will be undergoing craniotomy for tumor resection.
• Patient age 18 to 72 years.
• Karnofsky performance of 60% or greater
• Patients must have normal organ and marrow function as defined below:
• Leukocytes \>3,000/μL Absolute neutrophil count \>1,500/μL Platelets \>100,000/μL Total bilirubin within normal institutional limits AST (SGOT)/ALT (SGPT) \<2.5 X institutional upper limit of normal Creatinine within normal institutional limits or Creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
• The effects of Aminolevulinic Acid (ALA) on the developing human fetus are unknown. Therefore, 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.
• Patient must have the 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 the written informed consent.

You may not qualify if:

• Subjects with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA).
• Subjects with a history or family history of Porphyrias
• Subjects with 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.
• Pregnancy.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Department of Neurosurgery

San Francisco, California, 94143, United States

Location

Related Publications (1)

• Widhalm G, Olson J, Weller J, Bravo J, Han SJ, Phillips J, Hervey-Jumper SL, Chang SM, Roberts DW, Berger MS. The value of visible 5-ALA fluorescence and quantitative protoporphyrin IX analysis for improved surgery of suspected low-grade gliomas. J Neurosurg. 2019 May 10;133(1):79-88. doi: 10.3171/2019.1.JNS182614. Print 2020 Jul 1.

  PMID: 31075771 DERIVED

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Mitch Berger, MD; Director of Neurosurgery
• Organization: University of California San Francisco

Mtich.Berger@ucsf.edu

415-353-7500

Study Officials

• Mitchel S Berger, MD

  UCSF Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Chairman

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: August 1, 2010
• Primary Completion: December 28, 2017
• Study Completion: February 28, 2019
• Last Updated: May 29, 2019
• Results First Posted: May 29, 2019

Record last verified: 2019-05

Locations

US (1)