A Randomized Phase II Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck
- Determine the antiangiogenic effects of PEG-interferon alfa-2b, in terms of pre- and
post-treatment levels of microvessel density (MVD), endothelial cell apoptosis,
vascular endothelial growth factor (VEGF), interleukin-8, basic fibroblast growth
factor (bFGF), Nuclear Factor-KappaB (NF-KB), matrix metalloproteinase/MMP-9, and NF-KB
in biopsy specimens, from patients with resectable stage II-IV squamous cell carcinoma
of the head and neck.
- Determine the toxicity profile of this drug in these patients.
- Determine the clinical response in patients treated with this drug.
OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 4 treatment
- Arm I: Patients undergo surgery within 3 weeks after randomization.
- Arm II: Patients receive PEG-interferon alfa-2b subcutaneously on days 1, 8, and 15.
- Arm III: Patients receive PEG-interferon alfa-2b as in arm II but at a higher dose.
- Arm IV: Patients receive PEG-interferon alfa-2b as in arm II but at a higher dose than
in arm III.
In arms II, III, and IV, patients undergo surgery within 1 week after completion of
After completion of study treatment, patients are followed for up to 30 days.
PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
3 weeks following treatment
Roy S. Herbst, MD, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|