More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery



Status:Not yet recruiting
Conditions:Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:November 2015
End Date:September 2016
Contact:Costas Hadjipanayis, MD, PhD
Email:Constantinos.Hadjipanayis@mountsinai.org

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A Multicenter Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas

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.


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.

- 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.
We found this trial at
6
sites
550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Phone: 404-778-2981
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-936-9593
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30322
Phone: 404-778-2981
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Atlanta, Georgia 30342
Phone: 404-778-2981
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Detroit, Michigan 48202
Phone: 313-916-1827
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Detroit, MI
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-362-4313
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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