Immunoreactivity to Cetuximab in Cancer Patients

RATIONALE: Studying samples of blood in the laboratory may help doctors predict which patients will develop hypersensitivity to cetuximab.

PURPOSE: This research study is looking at hypersensitivity to cetuximab in patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab.

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Key information

Conditions

Colorectal Cancer Carcinoma Carcinoma, Squamous Cell Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Cranial Nerve Diseases Digestive System Diseases Digestive System Neoplasms Esthesioneuroblastoma, Olfactory Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Olfactory Nerve Diseases Rectal Diseases Rectal Neoplasms Salivary Gland Diseases Salivary Gland Neoplasms Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

OBJECTIVES:

To examine serum samples from patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab for the presence of antibodies against cetuximab.

OUTLINE: Serum samples are examined by immunoreactivity screening of IgE, IgG, IgA, and IgM antibodies and complement reaction.

Who can participate

Healthy volunteers accepted: No

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

DISEASE CHARACTERISTICS:

Diagnosis of one of the following:

Head and neck cancer
Advanced colorectal cancer
Previously treated with cetuximab
Serum samples available from patients enrolled in one of the following clinical trials:

VU-VICC-GI-0410 (colorectal cancer)
VU-VICC-GI-0622 (colorectal cancer)
VU-VICC-HN-0356 (head and neck cancer)

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Treatment and study plan

immunologic technique

Other

Sera from head and neck cancer or colorectal cancer patients who were treated with cetuximab will be obtained from Tumor Tissue Repository

Other names: None indicated

laboratory biomarker analysis

Other

Sera from head and neck cancer or colorectal cancer patients who were treated with cetuximab will be obtained from Tumor Tissue Repository

Other names: None indicated

Primary outcomes

Identification of antibodies (e.g., IgE, IgG, IgA, and IgM) against cetuximab

Time frame: Until all samples are collected.

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: May 12, 2009
Registry last updated: Apr 2, 2013

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.

Published trials that share one or more normalized conditions with this study.

Completed