Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer

Advanced Head and Neck Cancer patients receive gradually escalating doses of intravenous
Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached.
Treatment continues up to12 months in the absence of disease progression or unacceptable
toxicity.

OBJECTIVES:

- To determine the efficacy of Antineoplaston therapy in patients with advanced Head and
Neck Cancer, as measured by an objective response to therapy (complete response, partial
response or stable disease).

- To determine the safety and tolerance of Antineoplaston therapy in patients with
advanced Head and Neck Cancer.

- To determine objective response, tumor size is measured utilizing MRI scans, which are
performed every 8 weeks for the first two years, every 3 months for the third and fourth
years, every 6 months for the 5th and sixth years, and annually thereafter.

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