Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer

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