Thalidomide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria

• •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