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Zalutumumab in Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT00093041
First received: September 30, 2004
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  Purpose

The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.


Condition Intervention Phase
Head and Neck Neoplasms
 Drug: Zalutumumab
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Single Dose Escalation Study Followed by a Multiple Dose Extension of Anti-EGF Receptor Human Monoclonal Antibody (Zalutumumab) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genmab:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Overall Study ] [ Designated as safety issue: No ]
    Number of participants reporting at least one adverse event


Secondary Outcome Measures:
  • Overall Response, Classification [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Overall response was evaluated according to RECIST J Natl Cancer Inst 2000;92:205-16.


Enrollment: 28
Study Start Date: December 2003
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zalutumumab 0.15 mg/kg Drug: Zalutumumab
Weekly infusion
Experimental: Zalutumumab 0.5 mg/kg Drug: Zalutumumab
Weekly infusion
Experimental: Zalutumumab 1 mg/kg Drug: Zalutumumab
Weekly infusion
Experimental: Zalutumumab 2 mg/kg Drug: Zalutumumab
Weekly infusion
Experimental: Zalutumumab 4 mg/kg Drug: Zalutumumab
Weekly infusion
Experimental: Zalutumumab 8 mg/kg Drug: Zalutumumab
Weekly infusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The study population eligible for this study is adult male or female patients of good performance status having a histologically confirmed recurrent or metastatic SCCHN, not amenable to standard curative or palliative therapies.

  • Diagnosis of squamous cell carcinoma of the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx or larynx.
  • Primary or recurrent disease for which no curative or established palliative treatments are amenable
  • WHO performance status of 1 or 2.

Exclusion Criteria:

  • Received certain other treatments within 4 weeks prior to administration of study drug
  • Previous severe allergic reactions (e.g. angio-edema, severe asthma, or anaphylaxis).
  • Skin disease requiring systemic or local corticosteroid therapy.
  • Known brain metastasis or leptomeningeal disease.
  • Signs or symptoms of acute illness.
  • Bacterial, fungal or viral infection.
  • Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, myocardial infarction within one year and stomach, lung, heart, hormonal, nerve or blood diseases.
  • Pregnant or breast-feeding women.
  • Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial.
  • Simultaneous participation in any other trial involving investigational drugs or having participated in a trial within 4 weeks prior to start of trial treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093041

Locations
Denmark
Rigshospitalet
Copenhagen Ø, Denmark, 2100
Odense Universitetshospital
Odense, Denmark, 5000
Århus Kommunehospital
Århus C, Denmark, 8000
Sweden
Universitets Sjukhuset i Lund
Lund, Sweden, 221 85
Uppsala Akademiska Sjukhus
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Genmab
  More Information

Publications:

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT00093041     History of Changes
Other Study ID Numbers: Zalutumumab
Study First Received: September 30, 2004
Results First Received: September 12, 2011
Last Updated: November 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genmab:
Head and neck cancer
squamous cell carcinoma of the head and neck

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms, Squamous Cell
Neoplasms by Site
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013