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| ID | Type | Description | Link |
|---|---|---|---|
| WCI1999-11 | Other Identifier | Other | |
| R01CA176659 | U.S. NIH Grant/Contract | View source | |
| R21CA186169 | U.S. NIH Grant/Contract | View source | |
| IRB00051663 | Other Identifier | Emory University |
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| Name | Class |
|---|---|
| NX PharmaGen | UNKNOWN |
| National Cancer Institute (NCI) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-ALA (Gliolan) | Experimental | Fluorescent substance to help visualize and remove as much tumor as possible without harming healthy tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-ALA (Gliolan) | Drug | 20 mg/kg administered once 3-5 hours prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radicality of Brain Tumor Resection | Within the first 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival every 3 months after surgery | Every 3 months until tumor progression on MRI |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Costas Hadjipanayis, MD, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States | ||
| Emory University Winship Cancer Institute |
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| Atlanta |
| Georgia |
| 30322 |
| United States |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D005910 | Glioma |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |
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| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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