Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma
Malignant Mesothelioma
About this trial
This is an interventional treatment trial for Malignant Mesothelioma focused on measuring advanced malignant mesothelioma, recurrent malignant mesothelioma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IV mesothelioma that is unlikely to respond to existing therapy and for which no curative therapy exists Evidence of disease by CT scan or MRI PATIENT CHARACTERISTICS: Age: 1 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 2,000/mm^3 Platelet count at least 50,000/mm^3 Hepatic: Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal Hepatic function adequate Renal: Creatinine no greater than 2.5 mg/dL No renal insufficiency No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: No uncontrolled hypertension No history of congestive heart failure No cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No serious lung disease (e.g., chronic obstructive pulmonary disease) Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study participation Not at high medical or psychiatric risk No nonmalignant systemic disease No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent immunomodulatory agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: At least 8 weeks since prior radiotherapy (or less if multiple tumors) and recovered Surgery: Recovered from prior surgery Other: Prior cytodifferentiating agents allowed No prior antineoplastons No other concurrent antineoplastic agents
Sites / Locations
- Burzynski Clinic
Arms of the Study
Arm 1
Experimental
Arm: 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.