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A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
DUSA Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Jefferson W Chen, MD, Legacy Health System
ClinicalTrials.gov Identifier:
NCT01403311
First received: July 25, 2011
Last updated: March 24, 2014
Last verified: March 2014

July 25, 2011
March 24, 2014
October 2010
December 2011   (final data collection date for primary outcome measure)
Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively [ Time Frame: participants will be followed while in the hospital and for 12 weeks after surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01403311 on ClinicalTrials.gov Archive Site
Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA [ Time Frame: participants will be followed for 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioma
Drug: 5-Aminolevuline Acid
5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before surgery
Experimental: ALA
5-Aminolevuline Acid (ALA)
Intervention: Drug: 5-Aminolevuline Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18
March 2015
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01403311
5-ALA-01
Not Provided
Jefferson W Chen, MD, Legacy Health System
Legacy Health System
DUSA Pharmaceuticals, Inc.
Principal Investigator: Jefferson Chen, MD, PhD Legacy Health System
Legacy Health System
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP