Phase II Study of Antineoplastons A10 and AS2-1 Capsules With Total Androgen Blockade in Patients With Stage III or IV Adenocarcinoma of the Prostate

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically proven localized, regional, or metastatic adenocarcinoma of the
prostate

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 3 months

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- No hepatic failure

- Bilirubin no greater than 2.5 mg/dL

- SGOT no greater than 2 times normal

Renal:

- 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

Cardiovascular:

- No severe heart disease

Pulmonary:

- No severe lung disease

Other:

- Fertile patients must use effective contraception during and for 4 weeks after study
participation

- No serious active infections or fever

- No other prior or concurrent second malignancy within the past 2 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior biologic therapy and recovered

Chemotherapy:

- At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

- See Disease Characteristics

Radiotherapy:

- At least 4 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

Other:

- At least 4 weeks since prior investigational clinical trial

- No other concurrent treatment for metastatic prostate cancer