OBJECTIVES:

• Determine the response rate, time to progression, median survival, and percent of 1-year survival in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with fenretinide.
• Determine the pharmacokinetics and safety of this drug in these patients.

OUTLINE: Patients receive oral fenretinide every 12 hours on days 1-7. Treatment repeats every 3 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response continue treatment for 1 year.

PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC at least 3,000/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 9 g/dL

Hepatic:

• Transaminases no greater than 1.5 times normal
• Bilirubin no greater than 1.5 times normal

Renal:

• Creatinine no greater than 1.5 mg/dL

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile female patients must use 2 methods of effective contraception, 1 barrier and 1 hormonal, for at least 4 weeks before, during, and for 1 month after study
• Fertile male patients 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
• No other medical or social factors that would preclude compliance
• Able to take oral medications

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No more than 1 prior regimen of biologic therapy for metastatic disease
• If initially received adjuvant or induction chemotherapy and then recurred, no more than 1 additional biologic therapy regimen at time of recurrence

Chemotherapy:

• See Biologic therapy
• Prior induction chemotherapy or chemotherapy with radiotherapy allowed

• No more than 1 prior chemotherapy regimen for metastatic disease

  • Any number of courses of a particular chemotherapy regimen allowed
• If initially received adjuvant or induction chemotherapy and then recurred, no more than 1 additional chemotherapy regimen at time of recurrence
• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Chemotherapy
• Prior radiotherapy allowed
• No concurrent radiotherapy

Surgery:

• Prior surgery allowed

Other:

• No concurrent synthetic or natural vitamin A derivatives of 10,000 IU per day or more
• No concurrent antioxidants (e.g., vitamin E or vitamin C)