Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer

• Status: Withdrawn
• Trial end date: 1997-02-20
• Target enrollment: 0
• Participant gender: Male

Summary

Current therapies for Refractory Stage IV Prostate Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Refractory Stage IV Prostate Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Refractory Stage IV Prostate Cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Burzynski Research Institute

Criteria

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