Study of Proxinium for Treating Patients With Squamous Cell Head and Neck Cancer
Squamous Cell Carcinoma of the Head and Neck, Carcinoma, Squamous Cell, Neoplasms, Squamous Cell
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck
Eligibility Criteria
Inclusion Criteria: Disease Characteristics: Histologically confirmed recurrent squamous cell carcinoma of the head and neck. Immunohistochemically confirmed epithelial cell adhesion molecule (EpCAM)-positive SCCHN. Must have at least 1 accessible target tumor that is amenable to adequate direct injection. The patient must have at least 1 accessible target tumor without direct carotid artery involvement. Prior/Concurrent Therapy: The patient must have received therapy for their primary disease The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour. The patient's disease must be refractory. There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug. Patient Characteristics: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Life expectancy of at least 12 weeks. Adequate hepatic function ALT and AST and total bilirubin levels ≤1.5 times ULN. Adequate renal function (serum creatinine <2.0 mg/dL). Hematologic values consisting of granulocytes ≥1500/μL, platelets ≥100 000/μL, and hemoglobin >8 g/dL. Prothrombin time and partial thromboplastin time within normal limits Other: The patient must provide written informed consent. Fertile patients must use effective contraception Exclusion Criteria: Brain tumor or brain metastases. Nasopharyngeal SCCHN. Human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen. Uncontrolled bleeding from any target tumor(s) that are being considered for treatment or a history of tumor hemorrhage that has required medical intervention (other than direct compression). The patient is a candidate for surgical tumor resection of their target tumor(s). Pregnant or lactating. Clinically significant renal or hepatic disease. Requires regular use of aspirin, full-dose warfarin, or heparin.
Sites / Locations
- University of Alabama at Birmingham
- University of Arkansas for Medical Sciences
- UCLA Medical Center
- John P. Thropay, MD
- Mile High Oncology
- M.D. Anderson Cancer Center Orlando
- Evanston Northwestern Healthcare
- Ingalls Memorial Hospital
- University of Kansas Medical Center
- LSU Health Sciences Center
- Dana Farber Cancer Institute
- Dartmouth-Hitchcock Medical Center
- University of Oklahoma Health Sciences Center
- Portland VA Medical Center
- Hospital of the University of Pennsylvania
- Medical University of South Carolina
- Mary Crowley Medical Research Center
- Princess Margaret Hospital
- CHUQ, L'Hotel-Dieu de Quebec
Arms of the Study
Arm 1
Experimental
Dose Determination
The recommended dose (RD) for Proxinium is to be determined based on the rate of Dose Limiting Toxicities (DLT) within each dose cohort. The RD is to be established as the highest dose at which one or fewer patients out of six within a dose cohort experienced a DLT. The initial dose level is 500 μg of Proxinium in PBS (the amount of PBS used will be based on the estimated volume of the target tumour). Doses are to be escalated to a maximum of 700 μg or de-escalated to a minimum of 260 μg according to the prescribed algorithm outlined in the study protocol.