Trial | NCT00961090  Report issue

Title

Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    72
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.
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.
Study Started
Sep 30
2009
Primary Completion
Apr 22
2015
Study Completion
Apr 23
2015
Last Update
Apr 12
2019

Drug Aminolevulinic Acid

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

  • Other names: ALA

Single-Arm Other

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

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
No Results Posted