Wendy Cuthbert, Viventia Biotech
Study of Proxinium for Treating Patients With Squamous Cell Head and Neck Cancer
Recurrent Squamous Cell Carcinoma of the Head and Neck
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Head and Neck Cancer
The purpose of this study is to determine the safety, effectiveness, and recommended dose of
Proxinium in North American patients with Squamous Cell Head and Neck Cancer
Ages Eligible: 18 Years
Accepts Healthy Volunteers:
Histologically confirmed recurrent squamous cell carcinoma of the head and neck.
Immunohistochemically confirmed epithelial cell adhesion molecule (EpCAM)-positive
Must have at least 1 accessible target tumor that is amenable to adequate direct
The patient must have at least 1 accessible target tumor without direct carotid
The patient must have received therapy for their primary disease
The patient must have been diagnosed with persistent or recurrent disease or a second
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.
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
The patient must provide written informed consent.
Fertile patients must use effective contraception
- 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.
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
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Information objtained from ClinicalTrials.gov, on
4/25/2014. For additional information about
this and other clinical trials,
Please refer to this study by its ClinicalTrials.gov identifier: