Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Breast
Inclusion Criteria
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