A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors

Sponsor

MultiCare Health System Research Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT01351519

Collaborator

(none)

Enrollment

Location

Arm

44.1

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Glioma Glioma Glioblastoma Glioblastoma Multiforme Astrocytoma	Drug: Aminolevulinic Acid	Phase 2

Detailed Description

This is a Phase 2 study and all subjects will receive open label Aminolevulinic Acid in a dose of 20mg/kg given orally 3 hours prior to surgery. Brain tumors will be resected with the aid of ultraviolet light to visualize the tumor. After surgery an MRI will be done to determine whether the tumor has been completely or partially resected. All subjects will be followed for safety. All subjects will be followed closely by clinical examination and by MRI to monitor for disease recurrence.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aminolevulinic Acid (AL)	Drug: Aminolevulinic Acid Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery. Other Names: ALA 5-Aminolevulinic Acid Levulan

Arm

Intervention/Treatment

Experimental: Aminolevulinic Acid (AL)

Drug: Aminolevulinic Acid

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

Other Names:

ALA

5-Aminolevulinic Acid

Levulan

Outcome Measures

Primary Outcome Measures

Time to disease progression after initial surgery. [Up to 2 years]
Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.
Complete Resection [Day 2]
Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls

Secondary Outcome Measures

Determine the number of subjects with adverse events due to ALA in this dosage and indication. [Through 45 days]
Subjects will be followed closely for adverse events including biochemical abnormalities through laboratory monitoring and for clinically evident adverse events including possible skin reactions that may occur.
Overall Survival [Up to three years]
Determine the overall survival compared to historical controls.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MultiCare Health System Research Institute	Tacoma	Washington	United States	98405

Sponsors and Collaborators

MultiCare Health System Research Institute

Investigators

Principal Investigator: William Morris, MD, MultiCare Health System
Study Director: Richard Shine, PharmD, BCPS, MultiCare Health System Research Institute