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
Primary Purpose
Oral Mucositis
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SCV-07
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Oral Mucositis focused on measuring 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
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.
Sites / Locations
- Arizona Center for Cancer Care
- Arizona Oncology Services Foundation
- Arizona Clinical Research Center
- University of Arkansas for Medical Sciences
- Comprehensive Blood and Cancer Center
- Disney Family Cancer Center
- City of Hope National Medical Center
- VA Long Beach Health System
- Pomona Valley Hospital
- Yale University School of Medicine
- The Whittingham Cancer Center, Norwalk Hospital
- Helen F. Graham Cancer Center
- Washington Cancer Institute
- Lakeland Regional Cancer Center
- Lake County Oncology and Hematology
- The University of Illinois at Chicago
- St. John's Cancer Center
- University of Kentucky
- University of Louisville
- Mary Bird Perkins Cancer Center
- Louisiana State University Health Sciences Center
- University of Maryland Medical Center
- St. Agnes Hospital
- Southcoast Hospital Group
- Gershenson Radiation
- University of Minnesota
- Washington University in St. Louis
- The Nebraska Medical Center
- Veterans Administration NJ Health Care System
- Montefiore Medical Center
- New York Methodist Hospital
- Long Island Jewish Medical Center
- Beth Israel Medical Center
- Rochester University Medical Center
- Wake Forest University Health Sciences
- Summa Health System
- The Christ Hospital Cancer Center
- University of Oklahoma Health Science Center
- Providence Portland Medical Center
- Temple University Hospital
- Mount Nittany Medical Center
- Memorial Hospital of Rhode Island Cancer Center
- Medical University of South Carolina
- Cookeville Regional Cancer Center
- Kirkland Cancer Center/Jackson Madison County General Hospital
- Tyler Hematology Oncology
- Virginia Mason Medical Center
- Wheeling Hospital
- Medical College of Wisconson
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
SCV-07 0.1mg/kg
SCV-07 0.3mg/kg
SCV-07 1.0mg/kg
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Safety
The secondary objective of the study is to evaluate the safety and tolerability of SCV 07.
Full Information
NCT ID
NCT01247246
First Posted
November 22, 2010
Last Updated
May 22, 2014
Sponsor
SciClone Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01247246
Brief Title
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
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SciClone Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
SCV-07 0.1mg/kg
Arm Type
Active Comparator
Arm Title
SCV-07 0.3mg/kg
Arm Type
Active Comparator
Arm Title
SCV-07 1.0mg/kg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SCV-07
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Efficacy
Description
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.
Time Frame
June 2012
Secondary Outcome Measure Information:
Title
Safety
Description
The secondary objective of the study is to evaluate the safety and tolerability of SCV 07.
Time Frame
June 2012
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Israel Rios, MD
Organizational Affiliation
SciClone Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Center for Cancer Care
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Arizona Oncology Services Foundation
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
99309
Country
United States
Facility Name
Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
VA Long Beach Health System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Pomona Valley Hospital
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
The Whittingham Cancer Center, Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Helen F. Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19178
Country
United States
Facility Name
Washington Cancer Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Lakeland Regional Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Lake County Oncology and Hematology
City
Tavares
State/Province
Florida
ZIP/Postal Code
32778
Country
United States
Facility Name
The University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
St. John's Cancer Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Mary Bird Perkins Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
St. Agnes Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Southcoast Hospital Group
City
Fairhaven
State/Province
Massachusetts
ZIP/Postal Code
02719
Country
United States
Facility Name
Gershenson Radiation
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University in St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Veterans Administration NJ Health Care System
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn,
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Rochester University Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
The Christ Hospital Cancer Center
City
Cincinatti
State/Province
Ohio
Country
United States
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Mount Nittany Medical Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16803
Country
United States
Facility Name
Memorial Hospital of Rhode Island Cancer Center
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Cookeville Regional Cancer Center
City
Cookeville
State/Province
Tennessee
ZIP/Postal Code
38501
Country
United States
Facility Name
Kirkland Cancer Center/Jackson Madison County General Hospital
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Tyler Hematology Oncology
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Wheeling Hospital
City
Wheeling
State/Province
West Virginia
ZIP/Postal Code
26003
Country
United States
Facility Name
Medical College of Wisconson
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.sciclone.com
Description
SciClone Pharmaceuticals, Inc.
Learn more about this trial
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
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