Study of Proxinium for Treating Patients With Squamous Cell Head and Neck Cancer

Stopped early · Phase 2

Conditions studied: Squamous Cell Carcinoma of the Head and Neck, Carcinoma, Squamous Cell, Neoplasms, Squamous Cell, Head and Neck Neoplasms, Mouth Neoplasms, Head and Neck Cancer

In brief

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

Key facts

Study ID

NCT00272181

Run by

Sesen Bio, Inc.

People needed

15

Starts

2006-01-01

Expected to finish

2007-10-01

Last updated by the study team

2015-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• UCLA Medical Center — Los Angeles, California, United States
• John P. Thropay, MD — Montebello, California, United States
• Mile High Oncology — Denver, Colorado, United States
• M.D. Anderson Cancer Center Orlando — Orlando, Florida, United States
• Evanston Northwestern Healthcare — Evanston, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• LSU Health Sciences Center — Shreveport, Louisiana, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Portland VA Medical Center — Portland, Oregon, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada
• CHUQ, L'Hotel-Dieu de Quebec — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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