Glioblastoma
Conditions
Keywords
Brain tumor, glioma, surgical resection, ALA, ultraviolet light
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.
Interventions
20 mg/kg mixed in 50cc water and taken orally 3 hours prior to surgery
Sponsors
DUSA Pharmaceuticals, Inc.
Matthew R Quigley
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| More complete resection of malignant brain tumors | 3-7 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety of drug | 1 month |
Countries
United States
Outcome results
None listed