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Spots Global Cancer Trial Database for Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma

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Trial Identification

Brief Title: Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma

Official Title: A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEX^GM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease

Study ID: NCT00769704

Conditions

Melanoma

Study Description

Brief Summary: The objective of this study is to evaluate the efficacy and safety of treatment with talimogene laherparepvec compared to subcutaneously administered GM-CSF in patients with unresectable Stage IIIb, IIIc and Stage IV melanoma. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with talimogene laherparepvec as compared to GM-CSF.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Arizona Cancer Center, Tucson, Arizona, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

University of California San Diego, Moores Cancer Center, La Jolla, California, United States

UCLA Medical Center, Los Angeles, California, United States

San Francisco Oncology Associates, San Francisco, California, United States

Northern California Melanoma Center, St. Mary's Medical Center, San Francisco, California, United States

John Wayne Cancer Institute, Santa Monica, California, United States

Redwood Regional Medical Group Inc, North Bay Melanoma Program, Sebastopol, California, United States

University of Colorado Cancer Center, Aurora, Colorado, United States

Baptist Cancer Institute, Jacksonville, Florida, United States

Lakeland Regional Cancer Center, Lakeland, Florida, United States

Mount Sinai Medical Center CCOP, Miami Beach, Florida, United States

University of Miami, Miami, Florida, United States

MD Anderson Cancer Center Orlando, Orlando, Florida, United States

H. Lee Moffitt Cancer Center, Tampa, Florida, United States

Palm Beach Cancer Institute, West Palm Beach, Florida, United States

Emory University, Atlanta, Georgia, United States

Rush University Medical Center, Chicago, Illinois, United States

Cancer Care Center at Lutheran General Hospital, Park Ridge, Illinois, United States

Indiana University, Indianapolis, Indiana, United States

Investigative Clinical Research of Indiana, Indianapolis, Indiana, United States

University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States

University of Kansas Medical Center, Kansas City, Kansas, United States

James Graham Brown Cancer Center, Louisville, Kentucky, United States

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Hubert H Humphrey Cancer Center, Robbinsdale, Minnesota, United States

Mayo Clinic, Rochester, Minnesota, United States

Kansas City Cancer Center, Kansas City, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

St. Louis University Hospital, St. Louis, Missouri, United States

Methodist Estabrook Cancer Center, Omaha, Nebraska, United States

Mountainside Hospital, Morristown, New Jersey, United States

New Mexico Cancer Care Alliance, Albuquerque, New Mexico, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Columbia Medical University, New York, New York, United States

Mount Sinai School of Medicine, New York, New York, United States

University of North Carolina At Chapel Hill School of Medicine, Chapel Hill, North Carolina, United States

Duke University Medical Center, Durham, North Carolina, United States

Wake Forest University School of Medicine, Winston Salem, North Carolina, United States

Gabrail Cancer Center, Canton, Ohio, United States

Barrett Cancer Center, Cincinnati, Ohio, United States

Cleveland Clinic Foundation, Taussig Cancer Center, Cleveland, Ohio, United States

Earle A Chiles Research Institute, Providence Cancer Center, Portland, Oregon, United States

St Luke's Hospital & Health Network, Bethlehem, Pennsylvania, United States

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Rhode Island Hospital, Providence, Rhode Island, United States

Medical University of South Carolina, Charleston, South Carolina, United States

Institute for Translational Oncology Research, Greenville, South Carolina, United States

Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States

Texas Cancer Center, Abilene, Abilene, Texas, United States

Mary Crowley Medical Research Center, Dallas, Texas, United States

University of Texas - MD Anderson, Houston, Texas, United States

Texas Oncology, Allison Cancer Center, Midland, Texas, United States

Intermountain Medical Center, Murray, Utah, United States

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Oncology and Hematology Associates of Southwest Virginia, Inc., Salem, Virginia, United States

Aurora/St. Luke's Medical Center, Milwaukee, Wisconsin, United States

Cross Cancer Institute, Edmonton, Alberta, Canada

Princess Margaret Hospital, Toronto, Ontario, Canada

Jewish General Hospital, Montreal, Quebec, Canada

GVI Oncology, Port Elizabeth, Eastern Cape, South Africa

Dr. Fourie & Bonnet, Bloemfontein, Free State, South Africa

Medical Oncology Centre of Rosebank, Johannesburg, Gauteng, South Africa

Wits Donald Gordon Clinical Trial Site, Parktown, Guateng, South Africa

University of Pretoria, Pretoria, Guateng, South Africa

Mary Potter Oncology Centre, Pretoria, Guateng, South Africa

Hopelands Cancer Centre, Pietermaritzburg, Kwa-Zulu Natal, South Africa

Wilgers Oncology Center, Hatfield, Pretoria, South Africa

GVI Onocology Clinical Trials Unit, Cape Town, Western Cape, South Africa

GVI Oncology Centre, Cape Town, Western Cape, South Africa

University of Birmingham, Birmingham, , United Kingdom

Addenbrookes Hospital, Cambridge, , United Kingdom

Broomfield Hospital, Chelmsford, , United Kingdom

St. James's University Hospital, Leeds, , United Kingdom

Leicester Royal Infirmary, Leicester, , United Kingdom

Royal Free Hospital, London, , United Kingdom

St. George's University of London, London, , United Kingdom

Royal Marsden Hospital, London, , United Kingdom

Freeman Hospital, Newcastle upon Tyne, , United Kingdom

Nottingham City Hospital, Nottingham, , United Kingdom

Churchill Hospital, Oxford, , United Kingdom

Southampton General Hospital, Southampton, , United Kingdom

Clatterbridge Centre for Oncology, Wirral, , United Kingdom

Contact Details

Name: MD

Affiliation: Amgen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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