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Status:

TERMINATED

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

Lead Sponsor:

Sesen Bio, Inc.

Conditions:

Squamous Cell Carcinoma of the Head and Neck

Carcinoma, Squamous Cell

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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

Detailed Description

This study was an open-label, multicentre, dose determination study evaluating the safety and tolerability of Proxinium in the treatment of patients with advanced SCCHN who had received at least one a...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2007

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT00272181

Start Date

January 1 2006

End Date

October 1 2007

Last Update

December 23 2015

Active Locations (19)

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Page 1 of 5 (19 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294-3300

2

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

3

UCLA Medical Center

Los Angeles, California, United States, 90095

4

John P. Thropay, MD

Montebello, California, United States, 90640