Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Multiple Myeloma

Fecha de inicio: 4 de abril de 1996

DISEASE CHARACTERISTICS: Histologically and biochemically confirmed recurrent or progressing multiple myeloma that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy At least one standard first line therapy failure No localized plasmacytoma or plasmacytosis limited to the bone marrow Evidence of tumor by MRI or CT scan Presence of myeloma proteins in serum and urine, including Bence-Jones proteins 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: Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal No hepatic insufficiency Renal: Creatinine no greater than 2.5 mg/dL No renal problems No renal conditions that contraindicate high dosages of sodium Cardiovascular: No chronic heart failure No uncontrolled hypertension No history of congestive heart failure No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No severe 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 No serious medical or psychiatric disorders No active infections PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent immunomodulating agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No concurrent antineoplastic agents Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks) Surgery: Must be recovered from prior surgery Other: Prior cytodifferentiating agent allowed No prior antineoplaston therapy