Head and Neck Cancer Clinical Trial
Official title:
A Randomized Phase II Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck
RATIONALE: SCH 54031 (PEG-interferon alfa-2b) may interfere with the growth of tumor cells
and slow the growth of head and neck cancer. It may also stop the growth of head and neck
cancer by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b before surgery may
make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This randomized phase II trial is studying how well different doses of
PEG-interferon alfa-2b work in treating patients with stage II, stage III, or stage IV head
and neck cancer that can be removed by surgery.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
arms.
- 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
PEG-interferon alfa-2b.
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
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