NCT01403311

Brief Summary

This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

1.2 years

First QC Date

July 25, 2011

Last Update Submit

March 24, 2014

Conditions

Glioma

Keywords

Anaplastic astrocytomaAstrocytomaBrain stem gliomaEpendymomaGlioblastomaGlioblastoma multiformeGliosarcomaoligodendrogliomaMedulloblastomaMixed astrocytoma-ependymomaALA

Outcome Measures

Primary Outcomes (1)

  • Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively

    participants will be followed while in the hospital and for 12 weeks after surgery

Secondary Outcomes (1)

  • Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA

    participants will be followed for 24 months

Study Arms (1)

ALA

EXPERIMENTAL

5-Aminolevuline Acid (ALA)

Drug: 5-Aminolevuline Acid

Interventions

5-Aminolevuline AcidDRUG

5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before surgery

ALA

Eligibility Criteria

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

You may qualify if:

  • Patients must have clinically documented primary brain tumor for which resection is clinically indicated. The anticipated histology at resection should include: Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed astrocytoma-ependymoma
  • Patients may have prior therapy
  • years of age
  • Male or Female
  • Life expectancy is not a consideration for protocol entry
  • Patients must have normal organ and marrow function as defined below: Leukocytes \>3,000/mL, Absolute neutrophil count \>1,500/mL, Platelets \>100,000/mL, 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
  • Confirmation of Glial Tumor
  • Gross total resection is the aim of surgery
  • 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 a written informed consent.

You may not qualify if:

  • Non-Glial tumor i.e. tumor abscess, metastasis, lymphoma, vasculitis
  • Tumor with perforating vessels
  • Tumor involves critical fiber tracks
  • Use of the microsurgical tool monopolar loop
  • Subject has preexisting severe deficits concerning language or motor function not resolved with steroids
  • Performance Status of less than 60
  • Patients may not be receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA)
  • Personal or family history of porphorias
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Legacy Health System

Portland, Oregon, 97210, United States

Location

MeSH Terms

Conditions

GliomaAstrocytomaEpendymomaGlioblastomaGliosarcomaOligodendrogliomaMedulloblastoma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal Tumors, Primitive

Study Officials

  • Jefferson Chen, MD, PhD

    Legacy Health System

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 27, 2011

Study Start

October 1, 2010

Primary Completion

December 1, 2011

Study Completion

March 1, 2015

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

US(1)