A Phase II Study of Thalidomide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

Study start date: April 1, 1999

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck Recurrent disease OR metastatic disease at initial diagnosis or at recurrence Initial therapy of surgery and/or radiotherapy, induction chemotherapy, or concurrent chemotherapy and radiotherapy allowed No more than one prior regimen of chemotherapy or biologic therapy for metastatic disease Recurrence after adjuvant or induction chemotherapy may have received one additional course of chemotherapy or biologic therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 3 months WBC at least 3000/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 30% Bilirubin no greater than 1.5 times normal SGOT/SGPT no greater than 1.5 times normal Creatinine no greater than 1.5 mg/dL Not pregnant or nursing Negative pregnancy test Fertile women must use 2 methods of effective contraception, 1 barrier and 1 hormonal, beginning at least 4 weeks before study and continuing during and for 1 month after study Men must use effective barrier contraception during and for 1 month after study No grade 2 or greater peripheral neuropathy No serious infection or other concurrent illness requiring immediate therapy Must be able to take oral medications No medical or social factors that would interfere with compliance PRIOR CONCURRENT THERAPY: Any number of courses of one regimen of chemotherapy allowed No concurrent cytotoxic chemotherapy No concurrent radiotherapy