Clinical trial NCT01403311: A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
Official title: A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glioma
Keywords: Anaplastic astrocytoma
Astrocytoma
Brain stem glioma
Ependymoma
Glioblastoma
Glioblastoma multiforme
Gliosarcoma
oligodendroglioma
Medulloblastoma
Mixed astrocytoma-ependymoma
ALA
Lead sponsor: Legacy Health System
Sponsor class: OTHER
Collaborators: name: DUSA Pharmaceuticals, Inc.
First posted: 2011-07-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.

Detailed description: This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing brain tumors during surgery. When ALA is provided at an increased concentration, protoporphorin concentration in the malignant cell increases and renders the cell fluorescent under long ultraviolet light. This study looks at using oral ALA to help identify the tumor cells intraoperatively and facilitate complete resection.

Oral ALA will be given prior to image-guided microsurgical resection of the tumor. Following tumor resection under light microscopy, the tumor bed will be illuminated and any residual fluorescent tissue in cavity will be surgically removed leading to a more complete resection of tumor. Pathologic confirmation of tumor type will be made by neuropathology. Photosensitizer concentration in malignant and normal tissue will be estimated by fluorescence microscopy.

Eligibility criteria: Inclusion Criteria:

* Patients must have clinically documented primary brain tumor for which resection is clinically indicated. The anticipated histology at resection should include: Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed astrocytoma-ependymoma
* Patients may have prior therapy
* 18 years of age
* Male or Female
* Life expectancy is not a consideration for protocol entry
* Patients must have normal organ and marrow function as defined below: Leukocytes \>3,000/mL, Absolute neutrophil count \>1,500/mL, Platelets \>100,000/mL, Total bilirubin within normal institutional limits AST (SGOT)/ALT (SGPT)\<2.5 X institutional upper limit of normal, Creatinine within normal institutional limits or Creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
* Confirmation of Glial Tumor
* Gross total resection is the aim of surgery
* Ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Non-Glial tumor i.e. tumor abscess, metastasis, lymphoma, vasculitis
* Tumor with perforating vessels
* Tumor involves critical fiber tracks
* Use of the microsurgical tool monopolar loop
* Subject has preexisting severe deficits concerning language or motor function not resolved with steroids
* Performance Status of less than 60
* Prior therapy is not an exclusion criterion
* Patients may not be receiving any other investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA)
* Personal or family history of porphorias
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Primary outcomes:
measure: Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively
timeFrame: participants will be followed while in the hospital and for 12 weeks after surgery
Secondary outcomes:
measure: Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA
timeFrame: participants will be followed for 24 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Legacy Health System
state: Oregon
Study officials:
affiliation: Legacy Health System
name: Jefferson Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: