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

Primary Purpose

Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

aminolevulinic acid

therapeutic conventional surgery

About this trial

This is an interventional diagnostic trial for Adult Giant Cell Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (aminolevulinic acid)

Arm Description

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

Outcomes

Primary Outcome Measures

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).

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).

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT01575275

First Posted

April 9, 2012

Last Updated

July 5, 2018

Sponsor

Michael Vogelbaum, MD, PhD

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01575275

Brief Title

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

Official Title

A Phase 2 Comparative Study of 5-Aminolevulinic Acid (5-ALA) and Intraoperative MRI (iMRI) to Enhance Completeness of Resection of Glioblastoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Terminated

Why Stopped

Drugs unavailable

Study Start Date

May 2012 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michael Vogelbaum, MD, PhD

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (aminolevulinic acid)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

aminolevulinic acid

Other Intervention Name(s)

5-ALA, 5-Aminolaevulinic Acid, ALA

Intervention Description

Given PO

Intervention Type

Procedure

Intervention Name(s)

therapeutic conventional surgery

Intervention Description

Undergo surgery

Primary Outcome Measure Information:

Title

Description

Time Frame

Day 1

Title

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

Description

Time Frame

Up to day 1

Secondary Outcome Measure Information:

Title

Time Frame

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Vogelbaum, MD, PhD

Organizational Affiliation

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

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

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