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

NCT ID: NCT01351519

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-01-31

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.

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.

Conditions

Malignant Glioma; Glioma; Glioblastoma; Glioblastoma Multiforme; Astrocytoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aminolevulinic Acid (AL)

Group Type: EXPERIMENTAL

Aminolevulinic Acid

Intervention Type: DRUG

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

Interventions

Aminolevulinic Acid

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

Intervention Type: DRUG

Other Intervention Names

ALA; 5-Aminolevulinic Acid; Levulan

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MultiCare Health System Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Morris, MD

Role: PRINCIPAL_INVESTIGATOR

MultiCare Health System

Richard Shine, PharmD, BCPS

Role: STUDY_DIRECTOR

MultiCare Health System Research Institute

Locations

MultiCare Health System Research Institute

Tacoma, Washington, United States

Countries

United States

References

Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.

Reference Type: RESULT

PMID: 16648043 (View on PubMed)

Other Identifiers

ALA 11.07

Identifier Type: -

Identifier Source: org_study_id