A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by MultiCare Health System Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
MultiCare Health System Research Institute
ClinicalTrials.gov Identifier:
NCT01351519
First received: May 7, 2011
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Malignant Glioma
Glioma
Glioblastoma
Glioblastoma Multiforme
Astrocytoma
Drug: Aminolevulinic Acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

Resource links provided by NLM:


Further study details as provided by MultiCare Health System Research Institute:

Primary Outcome Measures:
  • Time to disease progression after initial surgery. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.

  • Complete Resection [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls


Secondary Outcome Measures:
  • Determine the number of subjects with adverse events due to ALA in this dosage and indication. [ Time Frame: Through 45 days ] [ Designated as safety issue: Yes ]
    Subjects will be followed closely for adverse events including biochemical abnormalities through laboratory monitoring and for clinically evident adverse events including possible skin reactions that may occur.

  • Overall Survival [ Time Frame: Up to three years ] [ Designated as safety issue: No ]
    Determine the overall survival compared to historical controls.


Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Aminolevulinic Acid
    Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.
    Other Names:
    • ALA
    • 5-Aminolevulinic Acid
    • Levulan
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351519

Contacts
Contact: Diane Miller, RN, MSN 253-403-5265 diane.miller@multicare.org
Contact: Christine Goetz, BS 253-403-7193 christine.goetz@multicare.org

Locations
United States, Washington
MultiCare Health System Research Institute Recruiting
Tacoma, Washington, United States, 98405
Contact: Richard Shine, PharmD, BCPS    253-403-7250    richard.shine@multicare.org   
Principal Investigator: William Morris, MD         
Sub-Investigator: Peter Brown, MD         
Sub-Investigator: Anthony Harris, MD, PhD         
Sponsors and Collaborators
MultiCare Health System Research Institute
Investigators
Principal Investigator: William Morris, MD MultiCare Health System
Study Director: Richard Shine, PharmD, BCPS MultiCare Health System Research Institute
  More Information

Publications:
Responsible Party: William Morris, MD, Principal Investigator, MultiCare Health System Research Institute
ClinicalTrials.gov Identifier: NCT01351519     History of Changes
Other Study ID Numbers: ALA 11.07
Study First Received: May 7, 2011
Last Updated: May 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by MultiCare Health System Research Institute:
Glioma
Glioblastoma
Glioblastoma Multiforme
Astrocytoma
Brain Tumor

Additional relevant MeSH terms:
Astrocytoma
Glioblastoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Aminolevulinic Acid
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014