NCT01351519

Brief Summary

In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue improves the surgeon's ability to completely resect or remove the brain tumor.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

3.7 years

First QC Date

May 7, 2011

Last Update Submit

March 15, 2016

Conditions

Malignant GliomaGliomaGlioblastomaGlioblastoma MultiformeAstrocytoma

Keywords

GliomaGlioblastomaGlioblastoma MultiformeAstrocytomaBrain Tumor

Outcome Measures

Primary Outcomes (2)

  • Time to disease progression after initial surgery.

    Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.

    Up to 2 years

  • Complete Resection

    Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls

    Day 2

Secondary Outcomes (2)

  • Determine the number of subjects with adverse events due to ALA in this dosage and indication.

    Through 45 days

  • Overall Survival

    Up to three years

Study Arms (1)

Aminolevulinic Acid (AL)

EXPERIMENTAL
Drug: Aminolevulinic Acid

Interventions

Aminolevulinic AcidDRUG

Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.

Also known as: ALA, 5-Aminolevulinic Acid, Levulan
Aminolevulinic Acid (AL)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically documented primary brain tumor for which surgical resection is indicated.
  • Age 18 years and older.
  • ECOG Performance status less than or equal to 2.
  • Laboratory values as follows:
  • Leukocytes greater than or equal to 3,000. ANC greater than or equal to 1,500. Platelets greater than or equal to 100,000. Total Bilirubin WNL. AST/ALT less than or equal to 2.5 times ULN. Creatinine WNL. or Creatinine Clearance greater than or equal to 60ml/min/1.73m2 if SCr above institutional normal.
  • Ability to provide informed consent or consent from a Legally Authorized Representative.

You may not qualify if:

  • Receipt of an investigational agent within 30 days.
  • Allergy to ALA or similar compounds.
  • Personal or family history of porphyria.
  • Uncontrolled intercurrent illness.
  • Inability to comply with the protocol.
  • Pregnancy, breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MultiCare Health System Research Institute

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

  • Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.

    PMID: 16648043RESULT

MeSH Terms

Conditions

GliomaGlioblastomaAstrocytomaBrain Neoplasms

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Levulinic AcidsKeto AcidsCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • William Morris, MD

    MultiCare Health System

    PRINCIPAL INVESTIGATOR

  • Richard Shine, PharmD, BCPS

    MultiCare Health System Research Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2011

First Posted

May 11, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 17, 2016

Record last verified: 2016-03

Locations

US(1)