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 studies the effectiveness of antineoplaston therapy in treating
patients who have refractory stage IV prostate cancer.
- Provide treatment with intravenous antineoplastons A10 and AS2-1 for patients with
incurable adenocarcinoma of the prostate who failed to respond to treatment with
antineoplaston A10 and AS2-1 capsules.
- Describe response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually increasing doses of antineoplaston A10 and antineoplaston AS2-1
by intravenous injection 6 times daily until the maximum tolerated dose is reached.
Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR.
Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
- Histologically confirmed incurable stage IV adenocarcinoma of the prostate that
failed to respond to treatment with antineoplaston A10 and AS2-1 capsules and for
which no curative therapy exists
- Evidence of tumor by MRI or CT scan
- No prostate-specific antigen (PSA) response to antiandrogen withdrawal
- If PSA changes used to indicate progressive disease, then PSA must increase more than
50% on two determinations at least 2 weeks apart
- 18 and over
- Karnofsky 60-100%
- At least 2 months
- Hemoglobin at least 9 g/dL
- WBC at least 2000/mm^3
- Platelet count at least 50,000/mm^3
- No hepatic insufficiency
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 5 times upper limit of normal
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
- No known chronic heart failure
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of
- No serious lung disease, such as severe chronic obstructive pulmonary disease
- Fertile patients must use effective contraception during and for 4 weeks after study
- Not a high medical or psychiatric risk
- No concurrent nonmalignant systemic disease that would preclude therapy
- No active infection
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior immunotherapy and recovered
- At least 4 weeks since prior chemotherapy and recovered
- See Disease Characteristics
- At least 4 weeks since prior hormonal therapy and recovered
- Concurrent corticosteroids allowed if dose is stable or decreasing
- At least 4 weeks since prior radiotherapy and recovered
- Recovered from prior surgery
- Prior cytodifferentiating agents allowed