Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer
Metastatic Prostate Cancer

About this trial
This is an interventional treatment trial for Metastatic Prostate Cancer focused on measuring adenocarcinoma of the prostate
Eligibility Criteria
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
Sites / Locations
- Burzynski Clinic
Arms of the Study
Arm 1
Experimental
Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.