Clinical trial NCT01247246: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Oral Mucositis
Keywords: Oral Mucositis
Head and Neck
Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
SCV-07
Lead sponsor: SciClone Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-11-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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 × 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:

* 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.

Primary outcomes:
measure: Efficacy
timeFrame: June 2012
Secondary outcomes:
measure: Safety
timeFrame: June 2012
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Arizona Center for Cancer Care
state: Arizona
city: Phoenix
country: United States
facility: Arizona Oncology Services Foundation
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Burbank
country: United States
facility: Disney Family Cancer Center
state: California
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Long Beach
country: United States
facility: VA Long Beach Health System
state: California
city: Pomona
country: United States
facility: Pomona Valley Hospital
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Norwalk
country: United States
facility: The Whittingham Cancer Center, Norwalk Hospital
state: Connecticut
city: Newark
country: United States
facility: Helen F. Graham Cancer Center
state: Delaware
city: Washington
country: United States
facility: Washington Cancer Institute
state: District of Columbia
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Tavares
country: United States
facility: Lake County Oncology and Hematology
state: Florida
city: Chicago
country: United States
facility: The University of Illinois at Chicago
state: Illinois
city: Anderson
country: United States
facility: St. John's Cancer Center
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: St. Agnes Hospital
state: Maryland
city: Fairhaven
country: United States
facility: Southcoast Hospital Group
state: Massachusetts
city: Detroit
country: United States
facility: Gershenson Radiation
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Omaha
country: United States
facility: The Nebraska Medical Center
state: Nebraska
city: East Orange
country: United States
facility: Veterans Administration NJ Health Care System
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn,
country: United States
facility: New York Methodist Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester University Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Cincinatti
country: United States
facility: The Christ Hospital Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: State College
country: United States
facility: Mount Nittany Medical Center
state: Pennsylvania
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island Cancer Center
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Cookeville
country: United States
facility: Cookeville Regional Cancer Center
state: Tennessee
city: Jackson
country: United States
facility: Kirkland Cancer Center/Jackson Madison County General Hospital
state: Tennessee
city: Tyler
country: United States
facility: Tyler Hematology Oncology
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Wheeling
country: United States
facility: Wheeling Hospital
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconson
state: Wisconsin
Study officials:
affiliation: SciClone Pharmaceuticals
name: Israel Rios, MD
role: STUDY_DIRECTOR
References: