Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Waldenstrom's Macroglobulinemia
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Confirmed diagnosis of Waldenstrom's macroglobulinemia
- Urine or serum protein electrophoresis showing a measurable monoclonal spike
- Indolent disease not yet requiring therapy allowed
- Positive delayed-type hypersensitivity (DTH) response
- Induration greater than 2 mm for at least 1 antigen
- No clinical signs or evidence of active brain involvement or leptomeningeal disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 50-100%
Life expectancy:
- At least 4 months
Hematopoietic:
- Neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 10 g/dL
Hepatic:
- Albumin at least 3.5 g/dL
- Bilirubin less than 2.0 mg/dL
- Transaminases no greater than 2.5 times upper limit of normal
Renal:
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No acute changes on EKG
- No uncontrolled angina
- No heart failure
- No arrhythmia
Other:
- Adequate nutritional intake as evidenced by total protein at least 60 g/L
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No concurrent gastrointestinal bleed
- No active bacterial infections such as abscess or with fistulae
- HIV negative
- No other concurrent non-malignant disease that would preclude study
- No history of alcoholism, drug addiction, or psychotic disorders that would preclude
follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- More than 4 weeks since prior immunotherapy
- More than 4 weeks since prior cytokines
- More than 4 weeks since prior plasmapheresis or plasma exchange
- No prior stem cell or bone marrow transplant
Chemotherapy:
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or
high-dose carboplatin)
- No prior intensive chemotherapy with stem cell support
Endocrine therapy:
- More than 4 weeks since prior corticosteroids
- No concurrent corticosteroids
Radiotherapy:
- More than 4 weeks since prior radiotherapy involving more than 25% of bone marrow
Surgery:
- Recovered from any prior surgery
- No prior organ transplant
Other:
- No other concurrent investigational agent
- No concurrent immunosuppressants
- No concurrent anti-inflammatory agents including aspirin and non-steroidal
anti-inflammatory agents