RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the
laboratory. Antineoplastons may inhibit the growth of cancer cells.
PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating
women with stage IV breast cancer that has not responded to standard therapy.
- Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in patients
with advanced breast cancer by determining the proportion of women who experience an
objective tumor response.
- Evaluate the adverse effects of and tolerance to this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive oral antineoplaston A10 and antineoplaston AS2-1 6 to 7 times per day.
Treatment continues for at least 6 weeks. Patients achieving complete or partial response
may continue on therapy until disease progression or toxic effects occur.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
- Histologically confirmed stage IV breast cancer that is unlikely to respond to
existing therapy and for which no curative therapy exists
- 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
- 18 and over
- Not specified
- Karnofsky 60-100%
- At least 2 months
- WBC at least 2,000/mm^3
- Platelet count at least 50,000/mm^3
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of normal
- No hepatic failure
- Creatinine no greater than 2.5 mg/dL
- No renal failure
- No chronic heart failure
- No uncontrolled hypertension
- No severe lung disease
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
- No serious medical or psychiatric disorders
- No active infections
- No other serious concurrent disease
- No serious malabsorption syndromes
PRIOR CONCURRENT THERAPY:
- Recovered from prior immunotherapy
- At least 4 weeks since prior immunotherapy, except in patients with disease
progression during or after initial therapy
- Recovered from prior chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas), except in
patients with disease progression during or after initial therapy
- Recovered from prior hormonal therapy
- At least 12 weeks since prior hormonal therapy, except in patients with disease
progression during and after initial therapy
- Concurrent corticosteroids for peritumoral edema allowed
- 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
- Recovered from any prior surgery
- No prior extensive stomach or intestinal surgery
- Prior cytodifferentiating agents allowed
- No prior antineoplaston therapy
- No other concurrent therapy for metastatic breast cancer