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

Conditions: Oral Mucositis

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.


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.

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