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

Oral Mucositis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01247246
• Other study ID #: SCI-SCV-MUC-P2b-002
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 22, 2010
• Last updated: May 22, 2014
• Start date: December 2010
• Est. completion date: June 2014

Study information

• Verified date: May 2014
• Source: SciClone Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
SciClone Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety	The secondary objective of the study is to evaluate the safety and tolerability of SCV 07.	June 2012	Yes

External Links

•   SciClone Pharmaceuticals, Inc.