Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for 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
Subject must have a body weight less than 150 kg at screening
Have recently-diagnosed, pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation therapy as first line treatment(postoperative patients are eligible, if surgery is \< 6 weeks prior to initiation of radiotherapy.
Plan to receive a continuous course of conventional external beam irradiation
Plan to receive a standard cisplatin chemotherapy regimen
You may not be if
Pregnant or breastfeeding
Have head and neck tumors of the lips, sinuses, salivary glands or unknown primary tumor
Prior radiation to the head and neck
Have a plan to receive cetuximab (Erbitux) in conjunction with chemotherapy
Had curative surgery more than 6 weeks prior to the initiation of radiotherapy
Have current oral mucositis
Presence of active infectious disease excluding oral candidiasis
Chronic immunosuppression
Seropositive for HIV or hepatitis B surface antigen or C antibody
Used an investigational agent within 30 days of randomization
Have a known sensitivity to any investigational agent
Clareo Health | Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer
