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Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01502605
Recruitment Status : Terminated (PI leaving institution)
First Posted : December 30, 2011
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:

This research is being done to study the safety and utility of 5-aminolevulinic acid (5-ALA) (also known as Gliolan) for identifying brain tumor tissue during surgery. The goal of this study is to determine if 5-ALA can differentiate between tumor and normal brain tissue.

Sometimes, during brain surgery, the removal of tumor tissue can be difficult because the tumor can look like normal brain tissue. Studies in other countries have shown that in some brain tumors, 5-ALA can make the tumors appear brighter under ultraviolet light. This may make it easier for doctors to remove as much tumor as safely as possible from your brain.

This study also hopes to see if 5-ALA can find different cell populations within the tumor that is removed and allow the researchers to better understand brain tumors.

The purpose of this study is to:

  • Find out how well 5-ALA can separate normal brain tissue from tumor tissues AND to see how well 5-ALA can find different cell populations within brain tumors
  • Identify the amount of 5-ALA that should be taken before surgery to make the tumors glow under ultraviolet light
  • Make sure the 5-ALA identifies tumor and not normal brain
  • Make sure 5-ALA does not cause any side effects

Condition or disease Intervention/treatment Phase
Astrocytoma Glioma Drug: 5-Aminolevulinic Acid Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
Study Start Date : September 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: 5-ALA
This arm will receive the investigational agent, 5-ALA.
Drug: 5-Aminolevulinic Acid
A one time, single-dose administration of ALA is planned 4 hours pre-operatively the day of surgery. ALA will be mixed in the minimum volume of sterile water or juice immediately before use and given as a single oral bolus. Once ALA has been administered, patients will be kept in subdued lighting away from sunlight.




Primary Outcome Measures :
  1. serious adverse event (SAE) Rate [ Time Frame: 2 weeks from dosing ]

    It will be considered as a serious adverse event with possible, probable, and definitely attribution to 5-ALA (SAE, detailed in section 8) if (within 2 weeks of dosing):

    Grade 1 or 2 LFT abnormalities not resolving within 2 weeks A single documented Grade 3 or 4 LFT abnormalities A Grade 3 or 4 skin photosensitivity



Secondary Outcome Measures :
  1. Diagnostic Accuracy [ Time Frame: 72 hours post-operative ]
    The secondary objective of the study is to estimate sensitivity (true positive rate) and specificity (true negative rate); false positive rate and false negative rate; positive predict rate, and negative predict rate using a 5-ALA dose of 20 mg/kg to delineate tumor that may provide discrimination between normal and malignant tissue intra-operatively.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have clinically documented primary brain tumor for which resection is clinically indicated. Radiographic findings should be consistent with high grade glioma. Intraoperative frozen section should either be: anaplastic astrocytoma (WHO Grade III astrocytoma) or glioblastoma (WHO Grade IV astrocytoma).
  • Patients must be aged greater than 18 years old
  • Karnofsky Performance Score > 70 (Appendix)
  • Patients must have normal organ and marrow function as defined below:

    • Leukocytes > 3,000 /uL
    • Absolute neutrophil count > 1,500/uL
    • Platelets > 100,000/uL
    • Total bilirubin within normal institutional limits
    • AST/ALT within normal institutional limits
    • Creatinine within normal institutional limits

Exclusion Criteria:

  • Prior craniotomy for resection, deep seated tumors in thalamus and brain stem.
  • History of allergic reactions to compounds of similar chemical composition to ALA.
  • Personal or family history of porphyrias
  • Personal history of hepatitis or other liver diseases.
  • Pregnant women are excluded from this study because ALA is of unknown teratogenic effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ALA, breastfeeding should be discontinued prior to treatment with ALA.
  • Inability to undergo magnetic resonance imaging (i.e. those patients with AICD/pacemakers).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502605


Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Alfredo Quinones, MD Johns Hopkins School of Medicine
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01502605    
Other Study ID Numbers: J1140
First Posted: December 30, 2011    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
5-ALA
Aminolevulinic Acid
Craniotomy
Brain Tumor
Surgical Resection
Neurosurgery
Additional relevant MeSH terms:
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Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents