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
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
1 other identifier
interventional
160
1 country
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2010
Typical duration for phase_2
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2010
CompletedFirst Posted
Study publicly available on registry
November 24, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMay 26, 2014
May 1, 2014
3.5 years
November 22, 2010
May 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy
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.
June 2012
Secondary Outcomes (1)
Safety
June 2012
Study Arms (4)
Placebo
PLACEBO COMPARATORSCV-07 0.1mg/kg
ACTIVE COMPARATORSCV-07 0.3mg/kg
ACTIVE COMPARATORSCV-07 1.0mg/kg
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
- 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 Ă— 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
- +2 more criteria
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Arizona Center for Cancer Care
Peoria, Arizona, 85381, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, 85013, United States
Arizona Clinical Research Center
Tucson, Arizona, 85715, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 99309, United States
Disney Family Cancer Center
Burbank, California, 91505, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
VA Long Beach Health System
Long Beach, California, 90822, United States
Pomona Valley Hospital
Pomona, California, 91767, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
The Whittingham Cancer Center, Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Helen F. Graham Cancer Center
Newark, Delaware, 19178, United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Lake County Oncology and Hematology
Tavares, Florida, 32778, United States
The University of Illinois at Chicago
Chicago, Illinois, 60612, United States
St. John's Cancer Center
Anderson, Indiana, 46016, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
St. Agnes Hospital
Baltimore, Maryland, 21229, United States
Southcoast Hospital Group
Fairhaven, Massachusetts, 02719, United States
Gershenson Radiation
Detroit, Michigan, 48201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
The Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Veterans Administration NJ Health Care System
East Orange, New Jersey, 07018, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Rochester University Medical Center
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Summa Health System
Akron, Ohio, 44304, United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Memorial Hospital of Rhode Island Cancer Center
Pawtucket, Rhode Island, 02860, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Cookeville Regional Cancer Center
Cookeville, Tennessee, 38501, United States
Kirkland Cancer Center/Jackson Madison County General Hospital
Jackson, Tennessee, 38301, United States
Tyler Hematology Oncology
Tyler, Texas, 75701, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Wheeling Hospital
Wheeling, West Virginia, 26003, United States
Medical College of Wisconson
Milwaukee, Wisconsin, 53226, United States
Related Links
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Israel Rios, MD
SciClone Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2010
First Posted
November 24, 2010
Study Start
December 1, 2010
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
May 26, 2014
Record last verified: 2014-05