Status:
UNKNOWN
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
Lead Sponsor:
SciClone Pharmaceuticals
Conditions:
Oral Mucositis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 rece...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01247246
Start Date
December 1 2010
End Date
June 1 2014
Last Update
May 26 2014
Active Locations (49)
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1
Arizona Center for Cancer Care
Peoria, Arizona, United States, 85381
2
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
3
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
4
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205