Solid Tumor
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Studying samples of tissue and blood in the laboratory from patients with cancer receiving epidermal growth factor receptor (EGFR) inhibitors may help doctors understand the effects of EGFR inhibitor therapy in the skin. PURPOSE: This laboratory study is looking at the effects of EGFR inhibitors in the skin of cancer patients.
Detailed description
OBJECTIVES: * Determine the effects of EGFR inhibitors on the EGFR pathway in the skin of cancer patients prior to and after receiving EGFR inhibitors (i.e., tyrosine kinase inhibitors and monoclonal antibodies). * Compare the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin of these patients. * Compare changes in the EGFR pathway with grade of rash in these patients. * Compare changes in EGFR pathway effectors in the skin with serum TGFα levels in these patients. OUTLINE: This is a pilot study. Patients undergo skin punch biopsies and blood sample collection at baseline, within 1 week of developing skin rash, and 6 weeks after beginning treatment. Samples are analyzed by immunohistochemistry and western blot for phosphorylated MAP kinase, AKT, and EGF levels and TGFα levels. Patients also complete diagrams to indicate locations of the rash once weekly during the first 6 weeks of treatment.
Interventions
enzyme inhibitor therapy
GENETICprotein expression analysis
protein expression analysis
OTHERimmunohistochemistry staining method
immunohistochemistry staining method
OTHERlaboratory biomarker analysis
laboratory biomarker analysis
PROCEDUREbiopsy
biopsy
Sponsors
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of a malignancy for which therapy on or off a clinical trial with an inhibitor of the EGFR pathway is under consideration * The therapy under consideration may be monotherapy or combined with other therapies as long as other therapies do not typically cause a rash PATIENT CHARACTERISTICS: * INR ≤ 3.0 (for patients receiving concurrent warfarin) * No severe underlying skin disorder (e.g., toxic epidermal necrolysis or severe dermatitis) that would preclude study treatment * No bleeding diatheses that would preclude safe biopsy * No allergy to lidocaine or similar local anesthetics PRIOR CONCURRENT THERAPY: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of EGFR inhibitors on the EGFR pathway in the skin prior to and after receiving EGFR inhibitors | baseline and at 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin | at 6 weeks |
| Comparison of changes in the EGFR pathway with grade of rash | at 6 weeks |
| Comparison of changes in EGFR pathway effectors in the skin with serum TGFα levels as assessed by immunohistochemistry and western blot | at 6 weeks |
Countries
United States
Outcome results
None listed