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

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.

Study Overview

• Status: Unknown
• Conditions: Oral Mucositis
• Intervention / Treatment: Drug: Placebo; Drug: SCV-07

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	The secondary objective of the study is to evaluate the safety and tolerability of SCV 07.	June 2012

Collaborators and Investigators

• Sponsor: SciClone Pharmaceuticals

Publications and helpful links

Helpful Links

• SciClone Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ANTICIPATED): June 1, 2014
• Study Completion (ANTICIPATED): June 1, 2014

Study Registration Dates

• First Submitted: November 22, 2010
• First Submitted That Met QC Criteria: November 22, 2010
• First Posted (ESTIMATE): November 24, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 26, 2014
• Last Update Submitted That Met QC Criteria: May 22, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Neoplasms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mucositis; Head and Neck; Head and Neck Neoplasms; Stomatitis; Neoplasms by Site; Stomatognathic Diseases; Oral Mucositis; Mouth Diseases; SCV-07
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Head and Neck Neoplasms; Mucositis; Stomatitis
• Other Study ID Numbers: SCI-SCV-MUC-P2b-002