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