Study Stopped
Slow accrual in North America
Study of Proxinium for Treating Patients With Squamous Cell Head and Neck Cancer
A Phase II, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Proxinium in Patients With Advanced SCCHN Who Have Received at Least One Anti-Cancer Treatment Regimen for Advanced Disease
1 other identifier
interventional
15
2 countries
19
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2006
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 3, 2006
CompletedFirst Posted
Study publicly available on registry
January 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedDecember 23, 2015
December 1, 2015
1.7 years
January 3, 2006
December 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the safety, tolerability and recommended dose (RD) of Proxinium
Weekly dosing
Study Arms (1)
Dose Determination
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
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).
- +5 more criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sesen Bio, Inc.lead
Study Sites (19)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
John P. Thropay, MD
Montebello, California, 90640, United States
Mile High Oncology
Denver, Colorado, 80210, United States
M.D. Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
LSU Health Sciences Center
Shreveport, Louisiana, 71103, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190, United States
Portland VA Medical Center
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75201, United States
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CHUQ, L'Hotel-Dieu de Quebec
Québec, Quebec, GIR 5C3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wendy Cuthbert
Sesen Bio, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2006
First Posted
January 4, 2006
Study Start
January 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
December 23, 2015
Record last verified: 2015-12