A Phase II Study of Thalidomide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck
I. Determine the effect of thalidomide on survival of patients with recurrent or metastatic
squamous cell carcinoma of the head and neck.
II. Determine clinical response rates following this therapy in these patients. III.
Determine the toxic effects of thalidomide in these patients. IV. Determine the effect of
thalidomide on tumor angiogenesis in these patients.
Patients receive 4-20 capsules of oral thalidomide once daily. Dose is escalated in
individual patients on a weekly basis for the first 5 weeks. Treatment continues in the
absence of disease progression or unacceptable toxicity, or for 12 months past complete
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Roy S. Herbst, MD, PhD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|