RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as sargramostim may protect normal cells from the side effects of radiation therapy. PURPOSE: Randomized phase II trial to determine the effectiveness of sargramostim in preventing mucositis in patients who are receiving radiation therapy for laryngeal cancer.

OBJECTIVES: I. Determine the efficacy of sargramostim (GM-CSF) in reducing the duration and severity of mucositis resulting from accelerated radiotherapy in patients with laryngeal carcinoma. II. Determine the effect of GM-CSF on quality of life aspects of these patients as assessed by nutritional status, analgesic use, and days in the hospital.

PROTOCOL OUTLINE: This is a randomized study. Patients receive radiotherapy in 16 fractions over 21 days. Patients are randomly allocated to one of two treatment arms before scheduled radiotherapy begins. Arm I: Patients receive sargramostim (GM-CSF) SC daily for 14 days beginning on day 14 of the course of radiotherapy. Arm II: Patients do not receive GM-CSF. Patients are followed weekly until mucositis is healed, as well as at weeks 2 and 6 following the end of radiotherapy.

PROJECTED ACCRUAL: A total of 34 patients (17 per arm) will be accrued for this study.

Ages Eligible for Study:  20 Years   -   80 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Diagnosis of laryngeal cancer with intention to treat by radiotherapy using a 16 fraction 3 week scheme Stage I or II
• No known CNS disease

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent immunotherapy
• Chemotherapy: No concurrent chemotherapy
• Endocrine therapy: No prior or concurrent corticosteroids No concurrent hormonal therapy
• Radiotherapy: See Disease Characteristics
• Surgery: No major organ allografts
• Other: No other concurrent investigational drugs

--Patient Characteristics--

• Age: 20 to 80
• Performance status: WHO 0-1
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Hepatic function normal
• Renal: Renal function normal
• Other: Not pregnant or nursing No serious active infection requiring antibiotic therapy No autoimmune disease No known seizures No psychosocial factors that would preclude study compliance No allergies to sargramostim (GM-CSF) Willingness to cooperate for regular mirror examination of the larynx