Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of the Stomach

Date de début de l'étude : 4 octobre 1996

DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the stomach that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan PATIENT CHARACTERISTICS: Age: 18 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: No hepatic insufficiency Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal Renal: No renal insufficiency 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 chronic obstructive pulmonary disease Other: Not pregnant or nursing 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 No concurrent immunomodulating 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 and recovered Surgery: Recovered from prior surgery Other: Prior cytodifferentiating agents allowed No other concurrent antineoplastic agents