Spots Global Cancer Trial Database for Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer
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Trial Identification
Brief Title: Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer
Official Title: A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Safety and Efficacy of SC-07 for the Delay to Onset of Severe Oral Mucositis in Subjects Receiving Chemoradiation Therapy for the Treatment of Cancers of the Head and Neck.
Study ID: NCT00756951
Study Description
Brief Summary: Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or radiation regiments used to treat cancer. This study examines the investigational drug SCV-07 and it's possible application in treating Oral Mucositis. Studies have shown that SCV-07 can possibly increase a broad immune system response, thus lowering the painful side effects experienced when treated for head and neck cancer. The purpose of this study is to assess the safety and tolerability of SCV-07 and it's ability to delay the onset of Oral Mucositis for patients receiving chemoradiation for head and neck cancer.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Arizona Oncology Services Foundation, Phoenix, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Whittingham Cancer Center, Norwalk, Connecticut, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
University of Illinois at Chicago, Chicago, Illinois, United States
James Graham Brown Cancer Center, Lousiville, Kentucky, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Washington University in St Louis, St Louis, Missouri, United States
The Nebraska Medical Center, Omaha, Nebraska, United States
Montefiore Medical Center, Bronx, New York, United States
Beth Israel Medical Center, New York, New York, United States
Carolinas Medical Center, Charlotte, North Carolina, United States
Mid Dakota Clinic, Bismarck, North Dakota, United States
Ohio State University Medical Center, Columbis, Ohio, United States
St Luke's Hospital & Health Network, Bethlehem, Pennsylvania, United States
Temple University, Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Israel Rios, MD
Affiliation: SciClone Pharmaceuticals
Role: STUDY_DIRECTOR
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