Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer
Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer
Current therapies for advanced Head and Neck Cancer provide very limited benefit to the
 patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
 beneficial in the treatment of advanced Head and Neck Cancer.

 PURPOSE: This study is being performed to determine the effects (good and bad) that
 Antineoplaston therapy has on 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