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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

Oral Mucositis

Interventions

SCV-07
Placebo

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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