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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Oral Mucositis

Thank you

Trial Information

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


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.

Type of Study:

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

Outcome Measure:

Efficacy

Outcome 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.

Outcome Time Frame:

June 2012

Safety Issue:

No

Principal Investigator

Israel Rios, MD

Investigator Role:

Study Director

Investigator Affiliation:

SciClone Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

SCI-SCV-MUC-P2b-002

NCT ID:

NCT01247246

Start Date:

December 2010

Completion Date:

May 2013

Related Keywords:

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

Name

Location

Medical University of South CarolinaCharleston, South Carolina  29425-0721
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
New York Methodist HospitalBrooklyn, New York  11215-3609
Beth Israel Medical CenterNew York, New York  10003
Virginia Mason Medical CenterSeattle, Washington  98111
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Summa Health SystemAkron, Ohio  44312
Montefiore Medical CenterBronx, New York  10467-2490
Mount Nittany Medical CenterState College, Pennsylvania  16803
City of Hope National Medical CenterLos Angeles, California  91010
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Washington Cancer InstituteWashington, District of Columbia  20010
University of MinnesotaMinneapolis, Minnesota  55455
Temple University HospitalPhiladelphia, Pennsylvania  19140
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Arizona Clinical Research CenterTucson, Arizona  85712
Helen F. Graham Cancer CenterNewark, Delaware  19713
Lakeland Regional Cancer CenterLakeland, Florida  33805
Providence Portland Medical CenterPortland, Oregon  97213-3635
University of LouisvilleLouisville, Kentucky  40202
Louisiana State University Health Sciences CenterShreveport, Louisiana  71130
University of KentuckyLexington, Kentucky  40536-0098
Yale University School Of MedicineNew Haven, Connecticut  06520
University of Maryland Medical CenterBaltimore, Maryland  21201-1595
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Wheeling HospitalWheeling, West Virginia  26003
The Nebraska Medical CenterOmaha, Nebraska  68198
University of Oklahoma Health Science CenterOklahoma City, Oklahoma  73104
The Christ Hospital Cancer CenterCincinnati, Ohio  45219
St. Agnes HospitalBaltimore, Maryland  21229
Washington University in St. LouisSt. Louis, Missouri  63110
Tyler Hematology OncologyTyler, Texas  75701
Arizona Center for Cancer CareGlendale, Arizona  85306
Lake County Oncology and HematologyThe Villages, Florida  32159
Disney Family Cancer CenterBurbank, California  91505
VA Long Beach Health SystemLong Beach, California  90822
Pomona Valley HospitalPomona, California  91767
The Whittingham Cancer Center, Norwalk HospitalNorwalk, Connecticut  06856
The University of Illinois at ChicagoChicago, Illinois  60612
St. John's Cancer CenterAnderson, Indiana  46016
Southcoast Hospital GroupFairhaven, Massachusetts  02719
Gershenson RadiationDetroit, Michigan  48201
Veterans Administration NJ Health Care SystemEast Orange, New Jersey  07018
Rochester University Medical CenterRochester, New York  14642
Memorial Hospital of Rhode Island Cancer CenterPawtucket, Rhode Island  02860
Cookeville Regional Cancer CenterCookeville, Tennessee  38501
Kirkland Cancer Center/Jackson Madison County General HospitalJackson, Tennessee  38301
Medical College of WisconsonMilwaukee, Wisconsin  53226