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

• Status: Terminated
• Trial end date: 2004-03-18
• Target enrollment: 0
• Participant gender: Male

Summary

Current therapies for Stage III or 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 Stage III or Stage IV Prostate Cancer.

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

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

Details

• Lead Sponsor: Burzynski Research Institute

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven stage III or IV adenocarcinoma of the prostate not potentially curable by surgery or radiotherapy

• Measurable tumors or tumor markers

• No response to antiandrogen withdrawal

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC at least 3000/mm^3

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

Hepatic:

• Bilirubin no greater than 2.5 mg/dL

• SGOT no greater than 2 times normal

• No hepatic failure

Renal:

• 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

• No chronic renal failure

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 infection or fever

• No other concurrent serious disease

• No other prior or concurrent malignancy within the past 2 years

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 and recovered

• Prior corticosteroids for at least 2 months allowed, but must be on stable or decreasing dose during study participation

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics

• At least 4 weeks since prior surgery and recovered

Other:

• At least 4 weeks since prior experimental clinical trial

• No other concurrent therapy for metastatic disease