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Keep this study
Lead
National Cancer Institute (NCI)
OBJECTIVES:
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.
OUTLINE:
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 response.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Thalidomide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
