Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer
Stage IV Prostate Cancer
About this trial
This is an interventional treatment trial for Stage IV Prostate Cancer focused on measuring Refractory stage IV prostate cancer
Eligibility 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
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.