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
patients with stage III or stage IV prostate cancer.
- Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in
combination with total androgen blockade in patients with localized, regional or
metastatic adenocarcinoma of the prostate by determining the proportion of patients 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 gradually escalating doses of antineoplastons A10 and AS2-1 capsules orally
6-7 times daily until the maximum tolerated dose is reached. Treatment continues for at
least 3 months in the absence of disease progression or unacceptable toxicity. Concurrently,
patients continue hormonal therapy with flutamide, leuprolide, or bicalutamide at the same
dose as before beginning antineoplaston therapy.
Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then
annually for 2 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
- Histologically proven localized, regional, or metastatic adenocarcinoma of the
- Progressive disease during prior hormonal therapy (both antiandrogen and
gonadotropin-releasing hormone) and must continue hormonal therapy
- Measurable tumors or tumor markers
- Bone metastases allowed
- 18 and over
- Karnofsky 60-100%
- At least 3 months
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- No hepatic failure
- Bilirubin no greater than 2.5 mg/dL
- SGOT no greater than 2 times normal
- No chronic renal failure
- BUN less than 60 mg/dL
- Creatinine no greater than 2.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
- Blood ammonia normal
- No severe heart disease
- No severe lung disease
- Fertile patients must use effective contraception during and for 4 weeks after study
- No serious active infections or fever
- No other prior or concurrent second malignancy within the past 2 years
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior biologic therapy and recovered
- At least 4 weeks since prior chemotherapy and recovered
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- Not specified
- At least 4 weeks since prior investigational clinical trial
- No other concurrent treatment for metastatic prostate cancer