Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery

NCT ID: NCT00961090

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2015-04-23

Brief Summary

A one time oral dose of ALA is taken before surgery. The medication makes the tumor visible under ultraviolet light which allow the surgeon to see more of the tumor for a more complete removal.

Detailed Description

Patients with primary neoplastic brain tumors (Grades II-IV) will participate in this trial. Each patient will have been evaluated and found to have such a tumor by history and recent imaging studies (MRI) and deemed a surgical candidate based on current neurosurgical standards of care.

Conditions

Glioblastoma

Study Design

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

Study Groups

Single-Arm

Single-Arm All subjects received 20mg/kg of Aminolevulinic Acid diluted in 50cc of water, orally, approximately 3 hours prior to surgery.

Group Type: OTHER

Aminolevulinic Acid

Intervention Type: DRUG

20 mg/kg mixed in 50cc water and taken orally 3 hours prior to surgery

Interventions

Aminolevulinic Acid

20 mg/kg mixed in 50cc water and taken orally 3 hours prior to surgery

Intervention Type: DRUG

Other Intervention Names

ALA

Eligibility Criteria

Inclusion Criteria

• Suspected primary brain tumor
• 18 years of age or more
• Normal marrow and organ function
• Eastern Cooperative Group performance status ≤ 2
• Women of childbearing potential must use adequate birth control
• Ability to understand and willingness to sign a written informed consent form
• Life expectancy not a consideration

Exclusion Criteria

• Receiving any other investigational agents
• History of allergic reactions to ALA
• Personal or family history of porphyrias
• Liver disease in the past year
• Uncontrolled intercurrent illness
• Pregnant or lactating women
• Inability to undergo MRI with contrast

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

Sponsors

DUSA Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Matthew R Quigley

OTHER

Sponsor Role: lead

Responsible Party

Matthew R Quigley

administrator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Matthew R Quigley, MD

Role: PRINCIPAL_INVESTIGATOR

The Guthrie Clinic

Locations

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

104974

Identifier Type: -

Identifier Source: org_study_id