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Zalutumumab in Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00093041
Recruitment Status : Completed
First Posted : October 1, 2004
Results First Posted : December 22, 2011
Last Update Posted : December 22, 2011
Sponsor:
Information provided by (Responsible Party):
Genmab

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

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: Zalutumumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : December 2003
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Overall Study ]
    Number of participants reporting at least one adverse event


Secondary Outcome Measures :
  1. Overall Response, Classification [ Time Frame: 8 weeks ]
    Overall response was evaluated according to RECIST J Natl Cancer Inst 2000;92:205-16.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT00093041     History of Changes
Other Study ID Numbers: Zalutumumab
First Posted: October 1, 2004    Key Record Dates
Results First Posted: December 22, 2011
Last Update Posted: December 22, 2011
Last Verified: November 2011

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

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