Spots Global Cancer Trial Database for Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer
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Trial Identification
Brief Title: Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer
Official Title: A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy
Study ID: NCT01247246
Conditions
Study Description
Brief Summary: This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial, initially stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be conducted in subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs) of the oral cavity, oropharynx, hypopharynx, or larynx. The study includes a treatment period of approximately 7 weeks, depending on the subject's prescribed radiation plan, and Week 1 and Week 4 post RT follow-up visits. It also includes a longer follow-up period of approximately 12 months to determine if there is an effect of SCV 07 on the tumor response to ChemoRT.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Center for Cancer Care, Peoria, Arizona, United States
Arizona Oncology Services Foundation, Phoenix, Arizona, United States
Arizona Clinical Research Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
Disney Family Cancer Center, Burbank, California, United States
City of Hope National Medical Center, Duarte, California, United States
VA Long Beach Health System, Long Beach, California, United States
Pomona Valley Hospital, Pomona, California, United States
Yale University School of Medicine, New Haven, Connecticut, United States
The Whittingham Cancer Center, Norwalk Hospital, Norwalk, Connecticut, United States
Helen F. Graham Cancer Center, Newark, Delaware, United States
Washington Cancer Institute, Washington, District of Columbia, United States
Lakeland Regional Cancer Center, Lakeland, Florida, United States
Lake County Oncology and Hematology, Tavares, Florida, United States
The University of Illinois at Chicago, Chicago, Illinois, United States
St. John's Cancer Center, Anderson, Indiana, United States
University of Kentucky, Lexington, Kentucky, United States
University of Louisville, Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
Louisiana State University Health Sciences Center, Shreveport, Louisiana, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
St. Agnes Hospital, Baltimore, Maryland, United States
Southcoast Hospital Group, Fairhaven, Massachusetts, United States
Gershenson Radiation, Detroit, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Washington University in St. Louis, St. Louis, Missouri, United States
The Nebraska Medical Center, Omaha, Nebraska, United States
Veterans Administration NJ Health Care System, East Orange, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
New York Methodist Hospital, Brooklyn,, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
Beth Israel Medical Center, New York, New York, United States
Rochester University Medical Center, Rochester, New York, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Summa Health System, Akron, Ohio, United States
The Christ Hospital Cancer Center, Cincinatti, Ohio, United States
University of Oklahoma Health Science Center, Oklahoma City, Oklahoma, United States
Providence Portland Medical Center, Portland, Oregon, United States
Temple University Hospital, Philadelphia, Pennsylvania, United States
Mount Nittany Medical Center, State College, Pennsylvania, United States
Memorial Hospital of Rhode Island Cancer Center, Pawtucket, Rhode Island, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Cookeville Regional Cancer Center, Cookeville, Tennessee, United States
Kirkland Cancer Center/Jackson Madison County General Hospital, Jackson, Tennessee, United States
Tyler Hematology Oncology, Tyler, Texas, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Wheeling Hospital, Wheeling, West Virginia, United States
Medical College of Wisconson, Milwaukee, Wisconsin, United States
Contact Details
Name: Israel Rios, MD
Affiliation: SciClone Pharmaceuticals
Role: STUDY_DIRECTOR
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