Clinical trial NCT00522834: Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma
Official title: A Randomized, Double-blind, Phase 3 Trial of Elesclomol (STA-4783) in Combination With Paclitaxel Versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects With Stage IV Metastatic Melanoma (SYMMETRY)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Melanoma
Keywords: melanoma
oncology
Stage IV Metastatic Melanoma
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2007-08-30
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: "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. "


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
* ECOG performance status of \<=2
* Measurable disease according to modified RECIST
* Life expectancy of greater than 12 weeks
* LDH \<= 2.0 x ULN
* Clinical lab values within protocol parameters.
* At least 18 years old and able and willing to provide informed consent to participate

Exclusion Criteria:

* Previous cytotoxic chemotherapy treatment for melanoma
* Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma.
* Presence of brain metastases
* Presence or history (\<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ
* Female subjects who are pregnant or nursing

Primary outcomes:
measure: Progression free survival
timeFrame: June 2009
Secondary outcomes:
measure: Overall Survival
timeFrame: December 2009
measure: Objective response rate
timeFrame: December 2009
measure: Clinical benefit rate
timeFrame: December 2009
measure: Duration of objective response
timeFrame: December 2009
measure: Safety
timeFrame: December 2009
measure: Pharmacokinetics
timeFrame: December 2009
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Little Rock
country: United States
facility: Winthrop P. Rockefeller Cancer Institute
state: Arkansas
city: La Jolla
country: United States
facility: University of California San Diego Moores UCSD Cancer Center
state: California
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic & Research Institute
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center Univ. of California Los Angeles
state: California
city: San Francisco
country: United States
facility: Pacific Medical Center Research Institute
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Medical Group
state: California
city: Aurora
country: United States
facility: Anschutz Cancer Pavillion University of Colorado
state: Colorado
city: Stamford
country: United States
facility: Hematology Oncology, P.C.
state: Connecticut
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: Miami
country: United States
facility: Univ. of Miami Hospital and Clinics
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: Rush University Hospital
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology/Hematology Associates, LTD
state: Illinois
city: Niles
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists, SC
state: Illinois
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute, Wayne State University
state: Michigan
city: Robbinsdale
country: United States
facility: Hubert H. Humphrey Cancer Center
state: Minnesota
city: Columbia
country: United States
facility: Ellis Fischels Cancer Center
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Hematology/Oncology
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Methodist Cancer Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Montclair
country: United States
facility: Atlantic Health Research - Mountainside Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Lake Success
country: United States
facility: Monter Cancer Center North Shore Hospital
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University - Division of Hematology and Medical Oncology
state: New York
city: New York
country: United States
facility: NYU Clinical Cancer Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center- Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: UNC School of Medicine - Division of Hematology/Oncology
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Hematology & Oncology Associates
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: Leo W. Jenkins Cancer Center
state: North Carolina
city: Greenville
country: United States
facility: Brody School of Medicine at East Carolina State University
state: North Carolina
city: Winston-Salem
country: United States
facility: Derrick L. Davis Regional Cancer Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University.
state: Ohio
city: Columbus
country: United States
facility: Mark H. Zangmeister Cancer Center
state: Ohio
city: Portland
country: United States
facility: Providence Cancer Center Clinical Trials
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center at University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Cancer Pavilion
state: Pennsylvania
city: Greenville
country: United States
facility: Cancer Center of the Carolinas
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology, PA
state: Texas
city: San Antonio
country: United States
facility: San Antonio Cancer Institute
state: Texas
city: Chesapeake
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Lismore
country: Australia
facility: Lismore Base Hospital, Cancer Care & Haematology Unit
state: New South Wales
city: Waratah
country: Australia
facility: Newcastle Melanoma Unit - Calvary Mater Newcastle
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre
state: New South Wales
city: Redcliffe
country: Australia
facility: Redcliffe Hospital
state: Queensland
city: Wooloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Adelaide
country: Australia
facility: Royal Adelaide Cancer Centre Medical Oncology
city: North Sydney
country: Australia
facility: Patricia Ritchie Centre for Cancer Care and Research, Mater Hospital
city: Tweed Heads
country: Australia
facility: The Tweed Hospital
city: Westmead
country: Australia
facility: Department of Medical Oncology, Westmead Hospital
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Halifax
country: Canada
facility: QE II Health Sciences Center
state: Nova Scotia
city: Sudbury
country: Canada
facility: Northeastern Ontario Regional Cancer Centre
state: Ontario
city: Edmonton
country: Canada
facility: Cross Cancer Institute
city: Toranto
country: Canada
facility: Princess Margaret Hospital
city: Berlin
country: Germany
facility: Vivantes Klinikum Im Friedrichshain
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Buxtehude
country: Germany
facility: Elbe-Klinikum Buxtehude
city: Frankfurt/Main
country: Germany
facility: University Frankfurt
city: Kiel
country: Germany
facility: University of Kiel
city: Köln
country: Germany
facility: Universität zu Köln
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: San Juan
country: Puerto Rico
facility: VA Medical Center
city: Brasov
country: Romania
facility: County Hospital Brasov - Oncology Department
city: Cluj Napoca
country: Romania
facility: Oncology Institute "Prof. Dr. Ion Chiricuta"
city: Hunedoara
country: Romania
facility: Clinical County Hospital " Alexandru Simionescu" Hunedoara
city: Iasi
country: Romania
facility: Center of Medical Oncology
city: Sibiu
country: Romania
facility: Clinical County Hospital Sibiu
city: Timisoara
country: Romania
facility: Oncology- Chemotherapy Clinic - Emergency Municipal Clinical Hospital
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Madrid
country: Spain
facility: Hospital Universitario de la Princessa Servicio de Oncología Médica
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud - Servicio de Oncología Médica Ciclos
city: Cambridge
country: United Kingdom
facility: Oncology Centre Addenbrookes's Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Treatment Newcastle General Hospital
city: Poole
country: United Kingdom
facility: Dorset Cancer Centre Poole Hospital NHS Foundation Trust
Study officials:
References:
citation: 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.