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"Elesclomol (STA-4783), N-malonyl-bis (N'-methyl-N'-thiobenzoylhydrazide) is a new chemical entity with a novel structure. STA-4783 induces an oxidative stress response in cells. This response is characterized by increased production of gene families that protect against different cellular stresses, including excessive heat, the presence of reactive oxygen species such as oxygen radicals, or the presence of heavy metals.
Subjects will participate in up to 2 weeks of screening during which time they will complete all screening procedures. Eligible subjects who have not received any prior cytotoxic chemotherapeutic agent for melanoma will be randomized in a 1:1 ratio to receive either STA-4783 213 mg/m2 in combination with paclitaxel 80 mg/m2 or paclitaxel 80 mg/m2 alone.
One treatment cycle will consist of weekly treatments for 3 weeks, followed by a 1-week rest period. Cycles will be repeated every 4 weeks until disease progression. Tumor assessments will be performed every 8 weeks from the date of randomization or sooner if the Investigator suspects progression has occurred based on clinical signs and symptoms. "
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Elesclomol (STA-4783) in Combination With Paclitaxel |
|
| 2 | Other | Paclitaxel alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elesclomol (STA-4783) | Drug | 213 mg/m2 Elesclomol (STA-4783) plus 80 mg/m2 paclitaxel administered intravenously once a week for the first 3 weeks of a 4 week cycle. Number of cycles: Until progression or unacceptable toxicity develops |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | June 2009 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | December 2009 | |
| Objective response rate | December 2009 | |
| Clinical benefit rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States | ||
| Winthrop P. Rockefeller Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23401447 | Derived | O'Day SJ, Eggermont AM, Chiarion-Sileni V, Kefford R, Grob JJ, Mortier L, Robert C, Schachter J, Testori A, Mackiewicz J, Friedlander P, Garbe C, Ugurel S, Collichio F, Guo W, Lufkin J, Bahcall S, Vukovic V, Hauschild A. Final results of phase III SYMMETRY study: randomized, double-blind trial of elesclomol plus paclitaxel versus paclitaxel alone as treatment for chemotherapy-naive patients with advanced melanoma. J Clin Oncol. 2013 Mar 20;31(9):1211-8. doi: 10.1200/JCO.2012.44.5585. Epub 2013 Feb 11. |
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| Paclitaxel | Drug | 80 mg/m2 paclitaxel alone administered intravenously once a week for the first 3 weeks of a 4 weeks cycle. Number of cycles: Until progression or unacceptable toxicity develops |
|
| December 2009 |
| Duration of objective response | December 2009 |
| Safety | December 2009 |
| Pharmacokinetics | December 2009 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| University of California San Diego Moores UCSD Cancer Center | La Jolla | California | 92093 | United States |
| University of California, San Diego | La Jolla | California | 92093 | United States |
| The Angeles Clinic & Research Institute | Los Angeles | California | 90025 | United States |
| Jonsson Comprehensive Cancer Center Univ. of California Los Angeles | Los Angeles | California | 90095 | United States |
| Pacific Medical Center Research Institute | San Francisco | California | 94115 | United States |
| Redwood Regional Medical Group | Santa Rosa | California | 94503 | United States |
| Anschutz Cancer Pavillion University of Colorado | Aurora | Colorado | 80010 | United States |
| Hematology Oncology, P.C. | Stamford | Connecticut | 06902 | United States |
| Bay Pines VA Healthcare System | Bay Pines | Florida | United States |
| Univ. of Miami Hospital and Clinics | Miami | Florida | 33136 | United States |
| MD Anderson Cancer Center | Orlando | Florida | 32806 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Rush University Hospital | Chicago | Illinois | United States |
| Evanston Northwestern Healthcare | Evanston | Illinois | 60201 | United States |
| Joliet Oncology/Hematology Associates, LTD | Joliet | Illinois | 60435 | United States |
| Oncology Specialists, S.C. | Niles | Illinois | 60714 | United States |
| Oncology Specialists, SC | Park Ridge | Illinois | 60068 | United States |
| Goshen Center for Cancer Care | Goshen | Indiana | 46526 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute, Wayne State University | Detroit | Michigan | United States |
| Hubert H. Humphrey Cancer Center | Robbinsdale | Minnesota | 55422 | United States |
| Ellis Fischels Cancer Center | Columbia | Missouri | United States |
| Southeast Nebraska Hematology/Oncology | Lincoln | Nebraska | 68510 | United States |
| Nebraska Methodist Cancer Center | Omaha | Nebraska | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Atlantic Health Research - Mountainside Hospital | Montclair | New Jersey | 07042 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131-0001 | United States |
| Monter Cancer Center North Shore Hospital | Lake Success | New York | United States |
| Weill Medical College of Cornell University - Division of Hematology and Medical Oncology | New York | New York | 10021 | United States |
| NYU Clinical Cancer Center | New York | New York | United States |
| Stony Brook University Medical Center- Cancer Center | Stony Brook | New York | 11794-9446 | United States |
| UNC School of Medicine - Division of Hematology/Oncology | Chapel Hill | North Carolina | 27599 | United States |
| Carolina Hematology & Oncology Associates | Charlotte | North Carolina | 28203 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Leo W. Jenkins Cancer Center | Greenville | North Carolina | 27834 | United States |
| Brody School of Medicine at East Carolina State University | Greenville | North Carolina | 27858 | United States |
| Derrick L. Davis Regional Cancer Center | Winston-Salem | North Carolina | 27103 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| The Ohio State University. | Columbus | Ohio | 43210 | United States |
| Mark H. Zangmeister Cancer Center | Columbus | Ohio | 43219 | United States |
| Providence Cancer Center Clinical Trials | Portland | Oregon | 97213 | United States |
| St. Luke's Cancer Center | Bethlehem | Pennsylvania | 18015 | United States |
| Abramson Cancer Center at University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Cancer Pavilion | Pittsburgh | Pennsylvania | 15323 | United States |
| Cancer Center of the Carolinas | Greenville | South Carolina | United States |
| Vanderbilt Medical Center | Nashville | Tennessee | 27232-6868 | United States |
| Texas Oncology, PA | Dallas | Texas | 75246 | United States |
| San Antonio Cancer Institute | San Antonio | Texas | 78229 | United States |
| Virginia Oncology Associates | Chesapeake | Virginia | 23320 | United States |
| Virginia Oncology Associates | Newport News | Virginia | 23606 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23230 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-1023 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| Lismore Base Hospital, Cancer Care & Haematology Unit | Lismore | New South Wales | Australia |
| Newcastle Melanoma Unit - Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| Southern Medical Day Care Centre | Wollongong | New South Wales | 2500 | Australia |
| Redcliffe Hospital | Redcliffe | Queensland | 4020 | Australia |
| Princess Alexandra Hospital | Wooloongabba | Queensland | 4102 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | Australia |
| Fremantle Hospital | Fremantle | Western Australia | 6160 | Australia |
| Royal Adelaide Cancer Centre Medical Oncology | Adelaide | SA 5000 | Australia |
| Patricia Ritchie Centre for Cancer Care and Research, Mater Hospital | North Sydney | Australia |
| The Tweed Hospital | Tweed Heads | Australia |
| Department of Medical Oncology, Westmead Hospital | Westmead | Australia |
| Tom Baker Cancer Centre | Calgary | Alberta | Canada |
| QE II Health Sciences Center | Halifax | Nova Scotia | Canada |
| Northeastern Ontario Regional Cancer Centre | Greater Sudbury | Ontario | Canada |
| Cross Cancer Institute | Edmonton | AB T6G 1Z2 | Canada |
| Princess Margaret Hospital | Toronto | Canada |
| Vivantes Klinikum Im Friedrichshain | Berlin | Germany |
| Vivantes Klinikum Neukölln | Berlin | Germany |
| Elbe-Klinikum Buxtehude | Buxtehude | Germany |
| Universität zu Köln | Cologne | Germany |
| University Frankfurt | Frankfurt am Main | Germany |
| University of Kiel | Kiel | Germany |
| Universitätsklinikum Leipzig | Leipzig | Germany |
| Universitätsklinikum Mannheim | Mannheim | Germany |
| Universitätsklinikum Münster | Münster | Germany |
| Universitätsklinikum Würzburg | Würzburg | Germany |
| VA Medical Center | San Juan | 00927 | Puerto Rico |
| County Hospital Brasov - Oncology Department | Brasov | 500 117 | Romania |
| Oncology Institute "Prof. Dr. Ion Chiricuta" | Cluj-Napoca | 400 015 | Romania |
| Clinical County Hospital " Alexandru Simionescu" Hunedoara | Hunedoara | 331 057 | Romania |
| Center of Medical Oncology | Iași | 700 106 | Romania |
| Clinical County Hospital Sibiu | Sibiu | 550 245 | Romania |
| Oncology- Chemotherapy Clinic - Emergency Municipal Clinical Hospital | Timișoara | 300 223 | Romania |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33006 | Spain |
| Hospital Universitario de la Princessa Servicio de Oncología Médica | Madrid | 28006 | Spain |
| Clinica Universitaria de Navarra | Pamplona | 31008 | Spain |
| Hospital Virgen de la Salud - Servicio de Oncología Médica Ciclos | Toledo | Spain |
| Oncology Centre Addenbrookes's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Northern Centre for Cancer Treatment Newcastle General Hospital | Newcastle upon Tyne | NE4 6BE | United Kingdom |
| Dorset Cancer Centre Poole Hospital NHS Foundation Trust | Poole | BH15 2JB | United Kingdom |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C512195 | elesclomol |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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