Zalutumumab in Head and Neck Cancer

Head and Neck Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00093041
• Other study ID #: Hx-EGFr-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 1, 2003
• Est. completion date: January 12, 2005

Study information

• Verified date: June 2023
• Source: Genmab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 12, 2005
• Est. primary completion date: January 12, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Zalutumumab
Weekly infusion

Locations

Country	Name	City	State
Denmark	Århus Kommunehospital	Århus C
Denmark	Rigshospitalet	Copenhagen Ø
Denmark	Odense Universitetshospital	Odense
Sweden	Universitets Sjukhuset i Lund	Lund
Sweden	Uppsala Akademiska Sjukhus	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Genmab

Countries where clinical trial is conducted

Denmark,  Sweden, 

References & Publications (1)

Bastholt L, Specht L, Jensen K, Brun E, Loft A, Petersen J, Kastberg H, Eriksen JG. Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of participants reporting at least one adverse event.	From study start (Day 0) until follow-up period (up to Day 77)
Secondary	Overall Response (OR), Classification	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.	8 weeks