Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer

OVERVIEW: This is a single arm, open-label study in which patients with Stage IV breast
cancer 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 Stage IV breast
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 Stage
IV breast 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 stage IV breast cancer that is unlikely to respond to
existing therapy and for which no curative therapy exists

- Must have failed prior standard therapy

- Measurable disease by MRI or CT scan

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

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal Status:

- Not specified

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:

- Bilirubin nor greater than 2.5 mg/dL

- SGOT/SGPT no greater than 5 times upper limit of normal

- No hepatic failure

Renal:

- Creatinine no greater than 2.5 mg/dL

- No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

- No chronic heart failure

- No uncontrolled hypertension

- No history of congestive heart failure

- No history of other cardiovascular conditions that contraindicate high dosages of
sodium

Pulmonary:

- No severe lung disease, such as chronic obstructive pulmonary disease

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 4 weeks after study
participation

- No serious medical or psychiatric disorders

- No active infections

- No other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy, except in patients with disease
progression during or after initial therapy

- Recovery from prior immunotherapy

- No concurrent immunomodulating agents

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas), except in
patients with disease progression during or after initial therapy

- Recovery from prior chemotherapy

- No concurrent antineoplastic agents

Endocrine therapy:

- At least 12 weeks since prior hormonal therapy, except in patients with disease
progression during and after initial therapy

- Concurrent corticosteroids allowed

- Recovery from prior hormonal therapy

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors
who have received radiotherapy to some, but not all, tumors may be admitted earlier
than 8 weeks)

Surgery:

- Recovered from any prior surgery

Other:

- No prior antineoplaston therapy

- Prior cytodifferentiating agent allowed