Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 60-100%

Life expectancy:

At least 2 months

Hematopoietic:

Hemoglobin at least 9 g/dL
WBC at least 2,000/mm^3
Platelet count at least 50,000/mm^3

Hepatic:

No hepatic insufficiency
Bilirubin no greater than 2.5 mg/dL
SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

Creatinine no greater than 2.5 mg/dL
No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

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 sodium

Pulmonary:

No serious lung disease, such as severe chronic obstructive pulmonary disease

Other:

Fertile patients must use effective contraception during and for 4 weeks after study participation
Not a high medical or psychiatric risk
No concurrent nonmalignant systemic disease
No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

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

Radiotherapy:

At least 4 weeks since prior radiotherapy and recovered

Surgery:

Recovered from prior surgery

Other:

Prior cytodifferentiating agent allowed