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| Name | Class |
|---|---|
| Cumberland Pharmaceuticals | INDUSTRY |
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This goal of this clinical trial is to evaluate how Acetadote affects metabolism in patients with glioblastoma. Drugs like Acetadote, which affect the level of damage in a cell (oxidative stress), may impact brain tumor metabolism and slow the growth of brain tumors.
The investigators are evaluating how Acetadote affects glioblastoma metabolism by using MRI-based methods and by determining the changes in metabolism in brain tumor tissue resected from patients with a new diagnosis of glioblastoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetadote 150 mg/kg IV | Experimental | Acetadote will be administered twice during this study: first before undergoing magnetic resonance spectroscopy (MRS) on Day 1 and second before undergoing surgical resection, which will take place between Days 2-21. Acetadote will be administered at a dose of 150 mg/kg IV over 60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetadote | Drug | Acetadote 150 mg/kg in 500 cc 5% dextrose IV over 1 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of Acetadote on glioblastoma metabolism as measured by MRS. | The effect of Acetadote on glioblastoma metabolism will be assessed by measuring cysteine, glutathione, and lactate in glioblastoma through MRS. | Day 1 and up to 21 days from Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of Acetadote on glioblastoma metabolism in resected tumor tissue as measured by LCMS | The effect of Acetadote on glioblastoma metabolism in resected tumor tissue will be measured by Liquid chromatography-mass spectrometry (LCMS). | Day 1 and up to 21 days from Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omar Raslan, MBBCH, MPH, CCRP | Contact | 214-648-7097 | omar.raslan@utsouthwestern.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |