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

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ClinicalTrials.gov Identifier: NCT01575275
Recruitment Status : Terminated (Drugs unavailable)
First Posted : April 11, 2012
Results First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michael Vogelbaum, MD, PhD, Case Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Interventions Drug: aminolevulinic acid
Procedure: therapeutic conventional surgery
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diagnostic (Aminolevulinic Acid)
Hide Arm/Group Description

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

aminolevulinic acid: Given PO

therapeutic conventional surgery: Undergo surgery

Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Diagnostic (Aminolevulinic Acid)
Hide Arm/Group Description

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

aminolevulinic acid: Given PO

therapeutic conventional surgery: Undergo surgery

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  75.0%
>=65 years
2
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
1
  12.5%
Male
7
  87.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diagnostic (Aminolevulinic Acid)
Hide Arm/Group Description:

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

aminolevulinic acid: Given PO

therapeutic conventional surgery: Undergo surgery

Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: cc
-0.342
(-2.604 to 1.096)
2.Primary Outcome
Title Comparison Between the Volume of Resected Tissue (Defined as the Volume of the Resection Cavity) and the Pre-operative Enhancing Tumor Volume
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome never analyzed. Study closed with the IRB in 2014
Arm/Group Title Diagnostic (Aminolevulinic Acid)
Hide Arm/Group Description:

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

aminolevulinic acid: Given PO

therapeutic conventional surgery: Undergo surgery

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame From the date of surgery with aminolevulinic acid to the date of progression, assessed up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome never analyzed. Closed with the IRB in 2014
Arm/Group Title Diagnostic (Aminolevulinic Acid)
Hide Arm/Group Description:

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

aminolevulinic acid: Given PO

therapeutic conventional surgery: Undergo surgery

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Overall Survival, by Periodic Follow up Review of the Patient Charts and by Correlation With the Social Security Death Index
Hide Description [Not Specified]
Time Frame From the date of surgery with aminolevulinic acid to the date of death, assessed up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diagnostic (Aminolevulinic Acid)
Hide Arm/Group Description:

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

aminolevulinic acid: Given PO

therapeutic conventional surgery: Undergo surgery

Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: months
16
(8 to 38)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diagnostic (Aminolevulinic Acid)
Hide Arm/Group Description

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

aminolevulinic acid: Given PO

therapeutic conventional surgery: Undergo surgery

All-Cause Mortality
Diagnostic (Aminolevulinic Acid)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Diagnostic (Aminolevulinic Acid)
Affected / at Risk (%) # Events
Total   3/8 (37.50%)    
Cardiac disorders   
Syncope * 1  1/8 (12.50%)  1
Nervous system disorders   
Infection * 1 [1]  1/8 (12.50%)  1
Vascular disorders   
Thrombosis/embolism * 1  1/8 (12.50%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Meningitis
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diagnostic (Aminolevulinic Acid)
Affected / at Risk (%) # Events
Total   5/8 (62.50%)    
Blood and lymphatic system disorders   
Anemia * 1  2/8 (25.00%)  2
Lymphopenia * 1  2/8 (25.00%)  2
Low Platelets * 1  2/8 (25.00%)  2
General disorders   
Pain * 1  2/8 (25.00%)  6
Infections and infestations   
Infection with unknown ANC - Meninges * 1  1/8 (12.50%)  1
Investigations   
hypoalbuminemia * 1  2/8 (25.00%)  3
Hypocalcemia * 1  1/8 (12.50%)  1
hyponatremia * 1  1/8 (12.50%)  1
Nervous system disorders   
Neuropathy: Sensory * 1  1/8 (12.50%)  1
Syncope * 1  1/8 (12.50%)  1
Renal and urinary disorders   
Urinary Frequency * 1  1/8 (12.50%)  1
Skin and subcutaneous tissue disorders   
Rash: hand-foot skin reaction * 1  1/8 (12.50%)  1
Vascular disorders   
Thrombosis * 1  1/8 (12.50%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Vogelbaum
Organization: Cleveland Clinic
Phone: 2164448564
EMail: vogelbm@ccf.org
Layout table for additonal information
Responsible Party: Michael Vogelbaum, MD, PhD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01575275    
Other Study ID Numbers: CASE1311
NCI-2012-00452 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: April 9, 2012
First Posted: April 11, 2012
Results First Submitted: August 3, 2015
Results First Posted: July 31, 2018
Last Update Posted: July 31, 2018