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
NCT ID: NCT00756951
Last Updated: 2009-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2008-09-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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1
Placebo
Placebo
Placebo
2
SCV-07 at a dose of 0.02 mg/kg
SCV-07
0.02 mg/kg
3
SCV-07 at a dose of 0.10 mg/kg
SCV-07
0.10 mg/kg
Interventions
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Placebo
Placebo
SCV-07
0.02 mg/kg
SCV-07
0.10 mg/kg
Eligibility Criteria
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Inclusion Criteria
* Have recently-diagnosed, pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation therapy as first line treatment(postoperative patients are eligible, if surgery is \< 6 weeks prior to initiation of radiotherapy.
* Plan to receive a continuous course of conventional external beam irradiation
* Plan to receive a standard cisplatin chemotherapy regimen
Exclusion Criteria
* Have head and neck tumors of the lips, sinuses, salivary glands or unknown primary tumor
* Prior radiation to the head and neck
* Have a plan to receive cetuximab (Erbitux) in conjunction with chemotherapy
* Had curative surgery more than 6 weeks prior to the initiation of radiotherapy
* Have current oral mucositis
* Presence of active infectious disease excluding oral candidiasis
* Chronic immunosuppression
* Seropositive for HIV or hepatitis B surface antigen or C antibody
* Used an investigational agent within 30 days of randomization
* Have a known sensitivity to any investigational agent
18 Years
ALL
No
Sponsors
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SciClone Pharmaceuticals
INDUSTRY
Responsible Party
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SciClone Pharmaceuticals, Inc.
Principal Investigators
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Israel Rios, MD
Role: STUDY_DIRECTOR
SciClone Pharmaceuticals
Locations
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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
Beth Israel Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, 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
Countries
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Related Links
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Related Info
Other Identifiers
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SCI-SCV-MUC-P2-001
Identifier Type: -
Identifier Source: org_study_id