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The purpose of this study is to find out how well an experimental drug called DepoCyt works for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine). Cytarabine has been used for many years to treat cancer.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal (injected into the spinal fluid) DepoCyt | Drug | |||
| Intrathecal methotrexate | Drug | |||
| Intrathecal cytarabine (also known as ara-C) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival, defined as the time to neurological progression or death |
| Measure | Description | Time Frame |
|---|---|---|
| Time to neurological progression; | ||
| Survival (all-cause and meningeal disease-specific) | ||
| Frequency of improvement in pre-existing meningeal-disease related neurological deficits |
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet Tutuncu, MD, PhD | Pacira Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| Alta Bates Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10589750 | Background | Glantz MJ, Jaeckle KA, Chamberlain MC, Phuphanich S, Recht L, Swinnen LJ, Maria B, LaFollette S, Schumann GB, Cole BF, Howell SB. A randomized controlled trial comparing intrathecal sustained-release cytarabine (DepoCyt) to intrathecal methotrexate in patients with neoplastic meningitis from solid tumors. Clin Cancer Res. 1999 Nov;5(11):3394-402. | |
| 10506606 |
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| Karnofsky Performance Scores (KPS) |
| Quality of life |
| Cytological response rate |
| Overall safety profile |
| Berkeley |
| California |
| 94704 |
| United States |
| University of Southern California, Norris Cancer Center | Los Angeles | California | 90033 | United States |
| University of Colorado Hospital, Anschutz Cancer Pavilion | Denver | Colorado | 80010 | United States |
| Georgetown University Medical Center Hematology/Oncology | Washington D.C. | District of Columbia | 20007 | United States |
| Mayo Clinic, Jacksonville | Jacksonville | Florida | 32224 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| Emory Clinic, Department of Neurosurgery | Atlanta | Georgia | 30322 | United States |
| Straub Clinic and Hospital | Honolulu | Hawaii | 96813 | United States |
| Rush Cancer Institute | Chicago | Illinois | 60612 | United States |
| Loyola University Medical Center, Dept. of Hematology/Oncology | Maywood | Illinois | 60153 | United States |
| Beth Israel Deaconess Medical Center Dept. of Neurology | Boston | Massachusetts | 02215 | United States |
| Park Nicollet Institute, Oncology Research Program | Minneapolis | Minnesota | 55416 | United States |
| JFK Neuroscience Institute | Edison | New Jersey | 08820 | United States |
| Bowman Gray School of Medicine/Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Case Western Reserve University Hospital of Cleveland | Cleveland | Ohio | 44106 | United States |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Health Science Center | San Antonio | Texas | 78284 | United States |
| University of Utah, Hunsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E0V9 | Canada |
| Toronto Sunnybrook Regional Cancer Center | Toronto | Ontario | M4N3M5 | Canada |
| Glantz MJ, LaFollette S, Jaeckle KA, Shapiro W, Swinnen L, Rozental JR, Phuphanich S, Rogers LR, Gutheil JC, Batchelor T, Lyter D, Chamberlain M, Maria BL, Schiffer C, Bashir R, Thomas D, Cowens W, Howell SB. Randomized trial of a slow-release versus a standard formulation of cytarabine for the intrathecal treatment of lymphomatous meningitis. J Clin Oncol. 1999 Oct;17(10):3110-6. doi: 10.1200/JCO.1999.17.10.3110. |
| ID | Term |
|---|---|
| D008577 | Meningeal Neoplasms |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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