Clinical trial NCT01351519: A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors
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: TERMINATED
Phase: PHASE2
Conditions: Malignant Glioma
Glioma
Glioblastoma
Glioblastoma Multiforme
Astrocytoma
Keywords: Glioma
Glioblastoma
Glioblastoma Multiforme
Astrocytoma
Brain Tumor
Lead sponsor: MultiCare Health System Research Institute
Sponsor class: OTHER
First posted: 2011-05-11
Enrollment: 16
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: 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.

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.

Primary outcomes:
measure: Time to disease progression after initial surgery.
timeFrame: Up to 2 years
measure: Complete Resection
timeFrame: Day 2
Secondary outcomes:
measure: Determine the number of subjects with adverse events due to ALA in this dosage and indication.
timeFrame: Through 45 days
measure: Overall Survival
timeFrame: Up to three years
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: MultiCare Health System Research Institute
state: Washington
Study officials:
affiliation: MultiCare Health System
name: William Morris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MultiCare Health System Research Institute
name: Richard Shine, PharmD, BCPS
role: STUDY_DIRECTOR
References:
citation: 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.