Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed recurrent or progressive Waldenstrom's macroglobulinemia 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
• •* Must have received and failed at least one standard first-line therapy (e.g., corticosteroid/alkylator combination)
• •Biochemical evidence of Waldenstrom's macroglobulinemia
• •* Abnormal proteins in serum and urine
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •Karnofsky 60-100%
• •Life expectancy:
• •At least 2 months
• •Hematopoietic:
• •WBC at least 2000/mm3
• •Platelet count at least 50,000/mm3
• •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 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
• •No active infection
• •No non-malignant systemic disease
• •Not a high medical or psychiatric risk
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •At least 4 weeks since prior immunotherapy
• •No concurrent immunomodulating agent
• •Chemotherapy:
• •See Disease Characteristics
• •At least 4 weeks (6 weeks since nitrosoureas) since prior chemotherapy
• •No concurrent antineoplastic agents
• •Endocrine therapy:
• •See Disease Characteristics
• •Concurrent corticosteroids allowed
• •Radiotherapy:
• •See Disease Characteristics
• •At least 8 weeks since prior radiotherapy
• •Surgery:
• •See Disease Characteristics
• •Recovered from prior surgery
• •Other:
• •No prior antineoplastons
• •Prior cytodifferentiating agents allowed