More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery
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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: NCT01445691 |
Recruitment Status :
Withdrawn
First Posted : October 4, 2011
Last Update Posted : May 17, 2016
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The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When the investigators remove the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red under blue light. This may make it easier for your doctor to take out all of the tumor from your brain. The purpose of this study is to:
- Make sure that 5-ALA helps the doctor remove more of the tumor.
- Make sure 5-ALA does not cause any side effects.
If you do not want to participate in this study, your doctor(s) will still do their best to remove all of the tumor in your brain. Whether or not you join this study will not change your treatment for your brain tumor.
Condition or disease | Intervention/treatment | Phase |
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Benign Neoplasms, Brain Brain Cancer Brain Neoplasms, Benign Brain Neoplasms, Malignant Brain Tumor, Primary Brain Tumor, Recurrent Brain Tumors Intracranial Neoplasms Neoplasms, Brain Neoplasms, Intracranial Primary Brain Neoplasms Primary Malignant Brain Neoplasms Primary Malignant Brain Tumors Gliomas Glioblastoma | Drug: 5-ALA (Gliolan) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas |
Study Start Date : | November 2015 |
Estimated Primary Completion Date : | September 2016 |
Estimated Study Completion Date : | September 2016 |

Arm | Intervention/treatment |
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Experimental: 5-ALA (Gliolan)
Fluorescent substance to help visualize and remove as much tumor as possible without harming healthy tissue.
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Drug: 5-ALA (Gliolan)
20 mg/kg administered once 3-5 hours prior to surgery
Other Names:
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- Radicality of Brain Tumor Resection [ Time Frame: Within the first 48 hours after surgery ]
- Progression-free survival every 3 months after surgery [ Time Frame: Every 3 months until tumor progression on MRI ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects must have a clinically documented primary brain tumor for which resection is clinically indicated. Individuals with suspected newly diagnosed or recurrent malignant gliomas will be considered eligible for the study. The anticipated histology at resection should include: Anaplastic astrocytoma (10002224), Anaplastic ependymoma, Anaplastic oligodendroglioma, Astrocytoma malignant NOS (10003572), Glioblastoma (10018336), Glioblastoma multiforme (10018337), or Gliosarcoma (10018340).
- Prior therapy is not a consideration in protocol entry.
- Age 18-80.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).
- Life expectancy is not a consideration for protocol entry.
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Subjects must have normal organ and marrow function as defined below:
- Leukocytes ≥ 3,000/mL
- Platelets ≥ 100,000/mL
- Total bilirubin below upper limit of normal
- Aspartate aminotransferase (AST) (SGOT)/alanine aminotransferase (ALT) (SGPT) ≤ 2.5 X institutional upper limit of normal
- Creatinine below upper limit of normal OR
- Creatinine clearance ≥ 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal
- The effects of aminolevulinic acid (ALA) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A pregnancy test will be performed for all women of childbearing ability prior to surgery. Women who are pregnant will be excluded from the trial.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Tumors of or involving the midline, basal ganglia, or brain stem as assessed by MRI.
- Subjects may not be receiving any experimental therapies.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA). Patients should refrain from use of other potential phototoxic substances (e.g. tetracyclines, sulfonamides,fluoroquinolones, hypericin extracts) for 72 hours.
- Personal or family history of porphyrias.
- 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. Pregnant women are excluded from this study because aminolevulinic acid (ALA) is of unknown teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with aminolevulinic acid (ALA), breastfeeding should be discontinued if the mother is treated with aminolevulinic acid (ALA).
- Women who are pregnant will be excluded from the trial.
- Prior history of GI perforation, diverticulitis, and/or peptic ulcer disease.
- Inclusion of women and minorities: both men and women and members of all ethnic groups are eligible for this trial.

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): NCT01445691
United States, Georgia | |
Emory University Hospital Midtown | |
Atlanta, Georgia, United States, 30308 | |
Emory University Winship Cancer Institute | |
Atlanta, Georgia, United States, 30322 | |
Emory Saint Joseph's Hospital | |
Atlanta, Georgia, United States, 30342 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
Henry Ford Health System | |
Detroit, Michigan, United States, 48202 | |
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Costas Hadjipanayis, MD, PhD | Icahn School of Medicine at Mount Sinai |
Responsible Party: | Constantinos Hadjipanayis, Professor and Chair, Neurosurgery, Icahn School of Medicine at Mount Sinai |
ClinicalTrials.gov Identifier: | NCT01445691 |
Other Study ID Numbers: |
GCO 15-2034 WCI1999-11 ( Other Identifier: Other ) R01CA176659 ( U.S. NIH Grant/Contract ) R21CA186169 ( U.S. NIH Grant/Contract ) IRB00051663 ( Other Identifier: Emory University ) |
First Posted: | October 4, 2011 Key Record Dates |
Last Update Posted: | May 17, 2016 |
Last Verified: | May 2016 |
Benign Neoplasms, Brain Brain Cancer Brain Neoplasms, Benign Brain Neoplasms, Malignant Brain Tumor, Primary Brain Tumor, Recurrent Brain Tumors Intracranial Neoplasms Neoplasms, Brain Neoplasms, Intracranial |
Primary Brain Neoplasms Primary Malignant Brain Neoplasms Primary Malignant Brain Tumors Gliomas Glioblastoma Surgery 5-ALA Aminolevulinic acid Fluorescence |
Neoplasms Glioblastoma Glioma Brain Neoplasms Recurrence Disease Attributes Pathologic Processes Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Aminolevulinic Acid Photosensitizing Agents Dermatologic Agents |