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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with stage III or stage IV prostate cancer.

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

Details

• Lead Sponsor: Burzynski Research Institute
• Treatments: Androgen Antagonists; Bicalutamide; Flutamide; Hormones; Leuprolide

Criteria

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