OBJECTIVES:

• Provide treatment with antineoplastons A10 and AS2-1 to patients with incurable cancer of the head and neck.
• Describe response to, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection six times per day until the maximum tolerated dose is reached.

Treatment continues for at least 2 months in the absence of disease progression or unacceptable toxicity. After 2 months, patients with stable or responding disease may continue treatment. Patients achieving complete response (CR) continue treatment for 8 months beyond CR.

Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed cancer of the head and neck that is unlikely to respond to existing therapy and for which no curative therapy exists

  • Metastatic disease OR incurable with surgery or radiation

• Measurable disease by CT scan or MRI

  • Tumor must be at least 2 cm for the lymph nodes located in the head, neck, axillary, inguinal or femoral areas and at least 0.5 cm for other areas

PATIENT CHARACTERISTICS:

Age:

• 16 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC at least 2,000/mm^3
• Platelet count at least 50,000/mm^3

Hepatic:

• No hepatic insufficiency
• Bilirubin no greater than 2.5 mg/dL
• SGOT and SGPT no greater than 2.5 mg/dL

Renal:

• No renal insufficiency
• Creatinine no greater than 2.5 mg/dL
• No renal conditions that contraindicate high dosages of sodium

Cardiovascular:

• No chronic heart failure
• No uncontrolled hypertension
• No history of congestive heart failure
• No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

• No serious lung disease (e.g., severe chronic obstructive pulmonary disease)

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 4 weeks after study participation
• No other serious medical or psychiatric conditions
• No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered
• No concurrent immunomodulatory agents

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
• No concurrent antineoplastic therapy

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• See Disease Characteristics
• At least 8 weeks since prior radiotherapy (unless multiple tumors) and recovered

Surgery:

• See Disease Characteristics

Other:

• Prior cytodifferentiating agents allowed