Clareo Health | 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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SciClone Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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:
* 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.
You may not be if
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.
