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Zalutumumab in Head and Neck Cancer

Primary Purpose

Head and Neck Neoplasms

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Zalutumumab
Sponsored by
Genmab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Head and neck cancer, squamous cell carcinoma of the head and neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rigshospitalet
  • Odense Universitetshospital
  • Århus Kommunehospital
  • Universitets Sjukhuset i Lund
  • Uppsala Akademiska Sjukhus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Zalutumumab 0.15 mg/kg

Zalutumumab 0.5 mg/kg

Zalutumumab 1 mg/kg

Zalutumumab 2 mg/kg

Zalutumumab 4 mg/kg

Zalutumumab 8 mg/kg

Arm Description

Outcomes

Primary Outcome Measures

Adverse Events
Number of participants reporting at least one adverse event.

Secondary Outcome Measures

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.

Full Information

First Posted
September 30, 2004
Last Updated
June 9, 2023
Sponsor
Genmab
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1. Study Identification

Unique Protocol Identification Number
NCT00093041
Brief Title
Zalutumumab in Head and Neck Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2003 (Actual)
Primary Completion Date
January 12, 2005 (Actual)
Study Completion Date
January 12, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genmab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
Head and neck cancer, squamous cell carcinoma of the head and neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zalutumumab 0.15 mg/kg
Arm Type
Experimental
Arm Title
Zalutumumab 0.5 mg/kg
Arm Type
Experimental
Arm Title
Zalutumumab 1 mg/kg
Arm Type
Experimental
Arm Title
Zalutumumab 2 mg/kg
Arm Type
Experimental
Arm Title
Zalutumumab 4 mg/kg
Arm Type
Experimental
Arm Title
Zalutumumab 8 mg/kg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zalutumumab
Other Intervention Name(s)
HuMax-EGFr
Intervention Description
Weekly infusion
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number of participants reporting at least one adverse event.
Time Frame
From study start (Day 0) until follow-up period (up to Day 77)
Secondary Outcome Measure Information:
Title
Overall Response (OR), Classification
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Århus Kommunehospital
City
Århus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Universitets Sjukhuset i Lund
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Uppsala Akademiska Sjukhus
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
17602769
Citation
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 the head and neck. Radiother Oncol. 2007 Oct;85(1):24-8. doi: 10.1016/j.radonc.2007.06.007. Epub 2007 Jun 28.
Results Reference
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Zalutumumab in Head and Neck Cancer

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