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 metastatic prostate cancer that has not responded to hormone therapy.
- Provide treatment with antineoplastons A10 and AS2-1 for patients with incurable,
metastatic, hormone-refractory adenocarcinoma of the prostate.
- Describe response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of antineoplaston A10 IV and antineoplaston
AS2-1 IV 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 with partial response or stable disease may continue treatment.
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 proven incurable, metastatic, hormone-refractory adenocarcinoma of the
prostate that is unlikely to respond to existing therapy
- Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan
- Stage D2
- 18 and over
- Karnofsky 60-100%
- At least 2 months
- Hemoglobin at least 9 g/dL
- WBC at least 2,000/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
- No active infection
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior immunotherapy and recovered
- At least 4 weeks since prior chemotherapy and recovered
- At least 4 weeks since prior hormonal therapy (unless progression documented upon
discontinuation of hormones)
- Concurrent corticosteroids allowed, if stable or decreasing for at least 2 months
before study entry
- At least 4 weeks since prior radiotherapy and recovered
- Recovered from prior surgery
- Prior cytodifferentiating agent allowed