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TerminatedNCT01575275Updated Jul 31, 2018Results posted

Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme

A Phase 2 interventional study of aminolevulinic acid and therapeutic conventional surgery in Adult Giant Cell Glioblastoma, Adult Glioblastoma and Adult Gliosarcoma, sponsored by Michael Vogelbaum, MD, PhD. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-31.

Sponsored by Michael Vogelbaum, MD, PhD · Phase 2, Interventional, and Diagnostic

Why this study was terminated
Drugs unavailable
Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate the safety and performance of an investigational agent, known as 5-ALA or Gliolan (aminolevulinic acid), that many be useful to a surgeon for visualizing a tumor during surgery. It is also being studied to determine if there are differences in what Gliolan shows a surgeon compared to intraoperative magnetic resonance imaging (MRI)

Read the detailed description

PRIMARY OBJECTIVES:

I. Determine the volume of residual enhancing tumor after a 5-ALA guided resection of a glioblastoma multiforme (GBM).

II. Determine the volume of tissue removed compared to the measured enhancing tumor evaluated on a pre-operative MRI.

SECONDARY OBJECTIVES:

I. Evaluate the time to tumor progression. II. Evaluate the overall survival.

OUTLINE:

Patients receive aminolevulinic acid orally (PO) 2-4 hours before surgery.

After completion of study treatment, patients are followed up for 2 weeks.

02

Conditions studied

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor
03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's enrollment of 8 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Michael Vogelbaum, MD, PhD is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have a suspected or biopsy proven newly diagnosed GBM, or a recurrent GBM or suspected GBM (in patient with pathologically diagnosed prior World Health Organization [WHO] grade II or III tumor) in a patient undergoing a clinically-indicated surgery.
  • Age >= 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky >= 60%)
  • Life expectancy is not a consideration for protocol entry
  • Patients must have normal organ and marrow function as defined below:
  • Absolute neutrophil count >= 1,500/uL
  • Platelets >= 100,000/uL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =\< 2.5 x institutional upper limit of normal
  • Creatinine within normal institutional limits; OR
  • Creatinine clearance >= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
  • 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; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • 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

Exclusion criteria

Exclusion Criteria:

  • Prior therapy is not an exclusion criterion
  • Patients may not be receiving any other investigational agents
  • History of allergic reactions attributed to aminolevulinic acid (ALA)
  • Current treatment with hypericin (or an extract) or other photosensitizing agents
  • Personal or immediate family (parents, siblings, children) history of porphyrias
  • 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
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ALA
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Diagnostic (aminolevulinic acid)

    Patients receive aminolevulinic acid PO 2-4 hours before surgery.

    Drug: aminolevulinic acid · Procedure: therapeutic conventional surgery

Interventions

  • Drugaminolevulinic acid

    Given PO

    Also known as: 5-ALA, 5-Aminolaevulinic Acid, ALA

  • Proceduretherapeutic conventional surgery

    Undergo surgery

06

What researchers measure

Primary outcomes

  1. Change in Volume of Residual Enhancing Tumor, as Determined by Intraoperative Volume MRI at a Single Time Point Without and With Gadolinium, Following Maximal Resection With Use of Aminolevulinic Acid

    Volume of enhancing tumor (initial and residual) will be determined by use of a softwarebased volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).

    Time frame: Day 1

  2. Comparison Between the Volume of Resected Tissue (Defined as the Volume of the Resection Cavity) and the Pre-operative Enhancing Tumor Volume

    Volume of enhancing tumor (initial and residual) will be determined by use of a software-based volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).

    Time frame: Up to day 1

Secondary outcomes

  1. Time to Disease Progression (TTP), Determined by Review of MRIs Performed Post Operatively as Clinically Indicated, Evaluated With Use of the New International Criteria Proposed by the Response in NeuroOncology (RANO) Committee

    Time frame: From the date of surgery with aminolevulinic acid to the date of progression, assessed up to 1 year

  2. Overall Survival, by Periodic Follow up Review of the Patient Charts and by Correlation With the Social Security Death Index

    Time frame: From the date of surgery with aminolevulinic acid to the date of death, assessed up to 4 years

07

Results

Posted Jul 31, 2018

Participant flow

Participant flow — Overall Study
MilestoneDiagnostic (Aminolevulinic Acid)
Started8
Completed8
Not completed0

Outcome measures

PrimaryChange in Volume of Residual Enhancing Tumor, as Determined by Intraoperative Volume MRI at a Single Time Point Without and With Gadolinium, Following Maximal Resection With Use of Aminolevulinic Acid

Volume of enhancing tumor (initial and residual) will be determined by use of a softwarebased volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).

Time frame:
Day 1
Reported as:
Median · cc
Change in Volume of Residual Enhancing Tumor, as Determined by Intraoperative Volume MRI at a Single Time Point Without and With Gadolinium, Following Maximal Resection With Use of Aminolevulinic Acid
ccDiagnostic (Aminolevulinic Acid)
Change in Volume of Residual Enhancing Tumor, as Determined by Intraoperative Volume MRI at a Single Time Point Without and With Gadolinium, Following Maximal Resection With Use of Aminolevulinic Acid-0.342 (-2.604 to 1.096)
PrimaryComparison Between the Volume of Resected Tissue (Defined as the Volume of the Resection Cavity) and the Pre-operative Enhancing Tumor Volume

Volume of enhancing tumor (initial and residual) will be determined by use of a software-based volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).

Time frame:
Up to day 1

No measurements were reported for this outcome.

SecondaryTime to Disease Progression (TTP), Determined by Review of MRIs Performed Post Operatively as Clinically Indicated, Evaluated With Use of the New International Criteria Proposed by the Response in NeuroOncology (RANO) Committee
Time frame:
From the date of surgery with aminolevulinic acid to the date of progression, assessed up to 1 year

No measurements were reported for this outcome.

SecondaryOverall Survival, by Periodic Follow up Review of the Patient Charts and by Correlation With the Social Security Death Index
Time frame:
From the date of surgery with aminolevulinic acid to the date of death, assessed up to 4 years
Reported as:
Median · months
Overall Survival, by Periodic Follow up Review of the Patient Charts and by Correlation With the Social Security Death Index
monthsDiagnostic (Aminolevulinic Acid)
Overall Survival, by Periodic Follow up Review of the Patient Charts and by Correlation With the Social Security Death Index16 (8 to 38)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Diagnostic (Aminolevulinic Acid)—3/8 (37.5%)5/8 (62.5%)
Most frequent serious events
Most frequent serious events
EventDiagnostic (Aminolevulinic Acid)
InfectionNervous system disorders1/8
SyncopeCardiac disorders1/8
Thrombosis/embolismVascular disorders1/8
Most frequent other events
Showing 10 of 13
Most frequent other events
EventDiagnostic (Aminolevulinic Acid)
hypoalbuminemiaInvestigations2/8
AnemiaBlood and lymphatic system disorders2/8
LymphopeniaBlood and lymphatic system disorders2/8
PainGeneral disorders2/8
Low PlateletsBlood and lymphatic system disorders2/8
HypocalcemiaInvestigations1/8
Infection with unknown ANC - MeningesInfections and infestations1/8
Neuropathy: SensoryNervous system disorders1/8
Rash: hand-foot skin reactionSkin and subcutaneous tissue disorders1/8
hyponatremiaInvestigations1/8

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Diagnostic (Aminolevulinic Acid)
<=18 years0
Between 18 and 65 years6
>=65 years2
Sex: Female, Male
Sex: Female, Male(Participants)Diagnostic (Aminolevulinic Acid)
Female1
Male7
Region of Enrollment
Region of Enrollment(participants)Diagnostic (Aminolevulinic Acid)
United States8
08

Study locations

1 site
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
    Cleveland, Ohio 44195, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01575275
Lead sponsor
Michael Vogelbaum, MD, PhD
Collaborators
National Cancer Institute (NCI)
Responsible party
Michael Vogelbaum, MD, PhD (Principal Investigator, Case Comprehensive Cancer Center) — Sponsor-investigator
First posted
Apr 11, 2012
Start date
May 2012
Primary completion
May 2014
Completion
Aug 2014
Results posted
Jul 31, 2018
Last update
Jul 31, 2018

Study contacts

Michael Vogelbaum, MD, PhD
principal investigator · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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