Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Soligenix
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant organ metastases
Scheduled to receive cisplatin chemotherapy of 80-100 mg/m²
Scheduled to receive a continuous course of fractionated, conventional external beam with a cumulative radiation dose between 55 and 72 Gy at each site
You may not be if
Current mucositis
Current, clinically significant, active infection that in the opinion of the Investigator would make them an unfit participant in the trial
Planned to receive Erbitux™ (Cetuximab) or similar targeted therapy between Baseline and 6 weeks post-RT
Prior radiation to the head and neck
Chemotherapy treatment within the previous 12 months
Tumors of the lips, sinuses, salivary glands, nasopharynx, hypopharynx, or larynx
Evidence of significant renal, hepatic, hematologic, or immunologic disease determined by any one of the following: Estimated creatinine clearance \<30 mL/min; ALT or AST level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal; Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy; Thrombocytopenia; or CD4+ T cell count below 200 cells per μL
Evidence of immediate life-threatening disease or a life expectancy of less than 3 months
Women who are pregnant or breast-feeding
Participation in any study involving administration of an investigational agent within 30 days of randomization into this study
Clareo Health | DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
