Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer

Refractory Stage IV Prostate Cancer patients receive gradually escalating doses of
intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose
is reached. Treatment continues up to 12 months in the absence of disease progression or
unacceptable toxicity.

OBJECTIVES:

- To determine the efficacy of Antineoplaston therapy in patients with Refractory Stage IV
Prostate Cancer, as measured by an objective response to therapy (complete response,
partial response or stable disease).

- To determine the safety and tolerance of Antineoplaston therapy in patients with
Refractory Stage IV Prostate Cancer.

- To determine objective response, tumor size is measured utilizing MRI scans, which are
performed every 8 weeks for the first two years, every 3 months for the third and fourth
years, every 6 months for the 5th and sixth years, and annually thereafter.

DISEASE CHARACTERISTICS:

- Histologically confirmed incurable stage IV adenocarcinoma of the prostate that failed
to respond to treatment with antineoplaston A10 and AS2-1 capsules and for which no
curative therapy exists

- Evidence of tumor by MRI or CT scan

- No prostate-specific antigen (PSA) response to antiandrogen withdrawal

- If PSA changes used to indicate progressive disease, then PSA must increase more than
50% on two determinations at least 2 weeks apart

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 2000/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 that would preclude therapy

- 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:

- See Disease Characteristics

- At least 4 weeks since prior hormonal therapy and recovered

- Concurrent corticosteroids allowed if dose is stable or decreasing

Radiotherapy:

- At least 4 weeks since prior radiotherapy and recovered

Surgery:

- Recovered from prior surgery

Other:

- Prior cytodifferentiating agents allowed