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A Phase II, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Proxinium in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck Who Have Received at Least One Anti-Cancer Treatment Regimen for Advanced Disease


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Squamous Cell Carcinoma of the Head and Neck, Carcinoma, Squamous Cell, Neoplasms, Squamous Cell, Head and Neck Neoplasms, Mouth Neoplasms, Head and Neck Cancer

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Trial Information

A Phase II, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Proxinium in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck Who Have Received at Least One Anti-Cancer Treatment Regimen for Advanced Disease


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety, tolerability and recommended dose (RD) of Proxinium

Outcome Time Frame:

Weekly dosing

Safety Issue:

Yes

Principal Investigator

Wendy Cuthbert

Investigator Role:

Study Director

Investigator Affiliation:

Viventia Biotech

Authority:

United States: Food and Drug Administration

Study ID:

VB4-845-01-IIA

NCT ID:

NCT00272181

Start Date:

January 2006

Completion Date:

October 2007

Related Keywords:

  • Recurrent Squamous Cell Carcinoma of the Head and Neck
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms
  • Mouth Neoplasms
  • Head and Neck Cancer
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Mouth Neoplasms
  • Neoplasms, Squamous Cell

Name

Location

Medical University of South CarolinaCharleston, South Carolina  29425-0721
Ingalls Memorial HospitalHarvey, Illinois  60426
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Evanston Northwestern HealthcareEvanston, Illinois  60201
Mary Crowley Medical Research CenterDallas, Texas  75246
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Portland VA Medical CenterPortland, Oregon  97239
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
UCLA Medical CenterLos Angeles, California  90095-7059
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Mile High OncologyDenver, Colorado  80210
LSU Health Sciences CenterShreveport, Louisiana  71130-3932
M.D. Anderson Cancer Center OrlandoOrlando, Florida  32806
John P. Thropay, MDMontebello, California  90640