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
NCT ID: NCT01247246
Last Updated: 2014-05-26
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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UNKNOWN
PHASE2
160 participants
INTERVENTIONAL
2010-12-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
SCV-07 0.1mg/kg
SCV-07
clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc
SCV-07 0.3mg/kg
SCV-07
clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc
SCV-07 1.0mg/kg
SCV-07
clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc
Interventions
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SCV-07
clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Have recently diagnosed, pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx, hypopharynx, or larynx that will be treated with ChemoRT as first-line treatment; subjects with a history of surgical management are eligible
* Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 to 2.2 Gy, with a cumulative radiation dose between 50 and 72 Gy. Planned radiation treatment fields must include at least 2 oral sites (buccal mucosa, floor of oral cavity, tongue, or soft palate), with each site receiving ≥ 50 Gy
* Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to 100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Have adequate hematopoietic, hepatic, and renal function at the screening visit:
* Hematopoietic function
* Hemoglobin ≥ 10 g/dL
* Absolute neutrophil counts (ANC) ≥ 1,500 cells/mm3
* Platelet count ≥ 100 × 109/L
* Hepatic function
* Total bilirubin \< 1.5 times the upper-normal limit (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 times the ULN
* Renal function: Serum creatinine concentration ≤ 2 mg/dL; if result is ≥ 1.4 mg/dL and ≤ 2.0 mg/dL, a 24-hour urinary creatinine clearance test must be performed by the site's local laboratory. To be eligible for the study, a subject must demonstrate a 24-hour urinary creatinine clearance ≥ 50 mL/min
* Have a negative serum pregnancy test if a woman is of childbearing potential
* Agree to use medically acceptable methods of birth control during study participation and for 30 days following the last CTM treatment if a woman is of childbearing potential
* Males or females aged 18 years or older.
Exclusion Criteria
* Metastatic disease (M1) Stage IV C
* Prior radiation to the head and neck
* Plan to be treated with cetuximab (Erbitux®)
* Have undergone induction CT
* History of other malignant tumors, excluding non-melanoma skin cancer or curatively excised in situ cervical carcinoma
* Have had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; anticipation of need for a major surgical procedure during the study
* Active infectious disease, excluding oral candidiasis
* Have OM at the baseline visit
* Have a diagnosis of autoimmune disease requiring chronic immunosuppression
* Known seropositivity for HIV, HBV, or HCV
* Prior use of SCV 07
* Have used any investigational agent within 30 days of randomization
* Are pregnant or breastfeeding
* Known allergies or intolerance to cisplatin
* Unable to give informed consent or comply with study requirements, including completing the subject diary and QOL instruments
* Have any other condition or therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with follow-up visits.
18 Years
ALL
No
Sponsors
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SciClone Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Israel Rios, MD
Role: STUDY_DIRECTOR
SciClone Pharmaceuticals
Locations
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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 D.C., 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
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
Montefiore Medical Center
The Bronx, 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
Cincinnati, 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
Countries
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Related Links
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SciClone Pharmaceuticals, Inc.
Other Identifiers
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SCI-SCV-MUC-P2b-002
Identifier Type: -
Identifier Source: org_study_id
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