Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer

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