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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
SciClone Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01247246
First received: November 22, 2010
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Oral Mucositis
Drug: SCV-07
Drug: Placebo
Phase 2

Study Type: Interventional
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
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

Resource links provided by NLM:


Further study details as provided by SciClone Pharmaceuticals:

Primary Outcome Measures:
  • Efficacy [ Time Frame: June 2012 ] [ Designated as safety issue: No ]
    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:
  • Safety [ Time Frame: June 2012 ] [ Designated as safety issue: Yes ]
    The secondary objective of the study is to evaluate the safety and tolerability of SCV 07.


Estimated Enrollment: 160
Study Start Date: December 2010
Estimated Study Completion Date: May 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo
Active Comparator: SCV-07 0.1mg/kg 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
Active Comparator: SCV-07 0.3mg/kg 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
Active Comparator: SCV-07 1.0mg/kg 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247246

  Hide Study Locations
Locations
United States, Arizona
Arizona Center for Cancer Care
Peoria, Arizona, United States, 85381
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 99309
Disney Family Cancer Center
Burbank, California, United States, 91505
City of Hope National Medical Center
Duarte, California, United States, 91010
VA Long Beach Health System
Long Beach, California, United States, 90822
Pomona Valley Hospital
Pomona, California, United States, 91767
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
The Whittingham Cancer Center, Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Delaware
Helen F. Graham Cancer Center
Newark, Delaware, United States, 19178
United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
United States, Florida
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
Lake County Oncology and Hematology
Tavares, Florida, United States, 32778
United States, Illinois
The University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Indiana
St. John's Cancer Center
Anderson, Indiana, United States, 46016
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
St. Agnes Hospital
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Southcoast Hospital Group
Fairhaven, Massachusetts, United States, 02719
United States, Michigan
Gershenson Radiation
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
United States, Nebraska
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Jersey
Veterans Administration NJ Health Care System
East Orange, New Jersey, United States, 07018
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
New York Methodist Hospital
Brooklyn,, New York, United States, 11215
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Beth Israel Medical Center
New York, New York, United States, 10003
Rochester University Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
The Christ Hospital Cancer Center
Cincinatti, Ohio, United States
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
United States, Rhode Island
Memorial Hospital of Rhode Island Cancer Center
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Cookeville Regional Cancer Center
Cookeville, Tennessee, United States, 38501
Kirkland Cancer Center/Jackson Madison County General Hospital
Jackson, Tennessee, United States, 38301
United States, Texas
Tyler Hematology Oncology
Tyler, Texas, United States, 75701
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
United States, West Virginia
Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Medical College of Wisconson
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
SciClone Pharmaceuticals
Investigators
Study Director: Israel Rios, MD SciClone Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: SciClone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01247246     History of Changes
Other Study ID Numbers: SCI-SCV-MUC-P2b-002
Study First Received: November 22, 2010
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by SciClone Pharmaceuticals:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Stomatitis
Mucositis
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 16, 2014