Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically proven stage II, III, or IV mantle cell lymphoma that is not curable by surgery, radiotherapy, and/or chemotherapy
• •Measurable tumor of greater than 2 cm in largest diameter for lymph nodes located in head, neck, axillary, inguinal, and femoral areas (at least 1 cm for other areas)
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •Karnofsky 60-100%
• •Life expectancy:
• •At least 2 months
• •Hematopoietic:
• •WBC greater than 2000/mm\^3
• •Platelet count greater than 20,000/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 hypertension
• •No history of congestive heart failure
• •No history of cardiovascular conditions that contraindicate high dosages of sodium
• •Other:
• •Not pregnant or nursing
• •Fertile patients must use effective contraception during and for 4 weeks after study participation
• •No serious active infections requiring treatment
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •At least 4 weeks since prior immunotherapy and recovered
• •No concurrent immunomodulatory agent (e.g., interferon or interleukin-2)
• •Chemotherapy:
• •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
• •No concurrent antineoplastic agent
• •Endocrine therapy:
• •At least 4 weeks since prior corticosteroids (e.g., dexamethasone or prednisone)
• •No concurrent dexamethasone, prednisone, or other corticosteroids
• •Radiotherapy:
• •At least 8 weeks since prior radiotherapy and recovered
• •Surgery:
• •Not specified
• •Other:
• •No prior antineoplaston therapy
• •No concurrent antibiotics, antifungals, or antivirals