Phase II Study of Neoadjuvant Immune Biomarker Modulation With Cetuximab Followed by Adjuvant Therapy With Concurrent Chemoradiotherapy or Radiotherapy With or Without Cetuximab for Locally Advanced Head and Neck Squamous Cell Carcinoma
This prospective phase II clinical trial of preoperative, single-agent cetuximab treated
patients is being conducted in order to obtain specimens before and after 4 weeks of
cetuximab for immune biomarker studies. Stage III/IV HNC patients will be treated with
definitive surgical resection and observed for disease recurrence. Cetuximab will be
administered for a 3-4 week preoperative period to study biomarker modulation in correlation
clinical response by CT scan and tumor apoptosis/proliferation after tumor excision,
immediately after neoadjuvant cetuximab but before surgery. We will biopsy the
skin/acneiform rash in all patients to correlate rash with biomarker modulation and clinical
response. Cetuximab may also be given in the adjuvant setting. A primary scientific
hypothesis will be tested: does short term pre-operative exposure to cetuximab modulate
blood immune biomarkers and is immune modulation associated with anti-tumor effect? Forty
(n=40) patients with complete specimens (tumor, peripheral blood mononuclear cells (PBMC)
and serum) are necessary to enable adequate statistical power to be reached using paired
specimens. A secondary set of hypotheses will evaluate the association between pre-operative
biomarker levels and modulation with disease recurrence. The proposed trial will accrue
stage II, III or IV surgical candidates without distant metastasis.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the extent to which immune biomarkers are modulated in peripheral blood and HNC tumors by preoperative treatment with 4 consecutive weeks of single-agent cetuximab
2 years
Yes
Rober L Ferris, MD, PhD
Principal Investigator
University of Pittsburgh Med Ctr (UPCI)
United States: Institutional Review Board
UPCI 08-013
NCT01218048
February 2011
January 2015
Name | Location |
---|---|
UPCI - Hillman Cancer Center | Pittsburgh, Pennsylvania 15232 |