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Completed

NCT Number: NCT00093041

Zalutumumab in Head and Neck Cancer

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

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Key information

Conditions

Head and Neck Neoplasms Carcinoma Carcinoma, Squamous Cell Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rigshospitalet, Copenhagen Ø, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed 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.

Treatment and study plan

Zalutumumab

Drug

Weekly infusion

Other names: HuMax-EGFr

Primary outcomes

  1. Adverse Events

    Time frame: From study start (Day 0) until follow-up period (up to Day 77)

    Number of participants reporting at least one adverse event.

Secondary outcomes

  1. Overall Response (OR), Classification

    Time frame: 8 weeks

    Best Overall Response is defined as the best response from the start of treatment until disease progression (PD) /recurrence and was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). As per RECIST, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions.

Sponsors and collaborators

Lead sponsor

Genmab

Industry

Registry information

Official study 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)

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Oct 1, 2004
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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