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
- Registration Number
- NCT01247246
- Lead Sponsor
- SciClone Pharmaceuticals
- 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
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
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Willing and able to understand and sign an informed consent form (ICF) for the study approved by the Investigator's local or a central Institutional Review Board (IRB)
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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
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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
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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)
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Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
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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
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Hepatic function
- Total bilirubin < 1.5 times the upper-normal limit (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 times the ULN
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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
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Have a negative serum pregnancy test if a woman is of childbearing potential
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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
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Males or females aged 18 years or older.
- Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo - SCV-07 0.1mg/kg SCV-07 - SCV-07 1.0mg/kg SCV-07 - SCV-07 0.3mg/kg SCV-07 -
- Primary Outcome Measures
Name Time Method Efficacy June 2012 The primary objective of the study is to evaluate the efficacy of SCV 07 in modifying the course of oral mucositis (OM) in subjects with head and neck cancer (HNC) receiving concurrent ChemoRT.
- Secondary Outcome Measures
Name Time Method Safety June 2012 The secondary objective of the study is to evaluate the safety and tolerability of SCV 07.
Trial Locations
- Locations (49)
The University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Disney Family Cancer Center
🇺🇸Burbank, California, United States
Arizona Oncology Services Foundation
🇺🇸Phoenix, Arizona, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Helen F. Graham Cancer Center
🇺🇸Newark, Delaware, United States
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
Louisiana State University Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Arizona Center for Cancer Care
🇺🇸Peoria, Arizona, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
VA Long Beach Health System
🇺🇸Long Beach, California, United States
The Whittingham Cancer Center, Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Pomona Valley Hospital
🇺🇸Pomona, California, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Lake County Oncology and Hematology
🇺🇸Tavares, Florida, United States
St. John's Cancer Center
🇺🇸Anderson, Indiana, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Southcoast Hospital Group
🇺🇸Fairhaven, Massachusetts, United States
Washington University in St. Louis
🇺🇸St. Louis, Missouri, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
St. Agnes Hospital
🇺🇸Baltimore, Maryland, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Gershenson Radiation
🇺🇸Detroit, Michigan, 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
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Rochester University Medical Center
🇺🇸Rochester, New York, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
Summa Health System
🇺🇸Akron, Ohio, United States
The Christ Hospital Cancer Center
🇺🇸Cincinatti, Ohio, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Mount Nittany Medical Center
🇺🇸State College, Pennsylvania, United States
Memorial Hospital of Rhode Island Cancer Center
🇺🇸Pawtucket, Rhode Island, United States
Cookeville Regional Cancer Center
🇺🇸Cookeville, Tennessee, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Kirkland Cancer Center/Jackson Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Medical College of Wisconson
🇺🇸Milwaukee, Wisconsin, United States
Wheeling Hospital
🇺🇸Wheeling, West Virginia, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Tyler Hematology Oncology
🇺🇸Tyler, Texas, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Lakeland Regional Cancer Center
🇺🇸Lakeland, Florida, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States