Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia

Phase II Study of Campath-1H in Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H antibody in the treatment of lymphoplasmacytic lymphoma.

• Patients will receive 3 test doses of Campath-1H (3mg, 10mg, 30mg). If the patient tolerates these three test doses, then they will receive a total of 6 weeks of Campath-1H therapy three times a week.
• After the patient receives the first 6 weeks of therapy at the 30mg therapeutic dose they will be re-assessed by blood testing. If it is determined that their disease has progressed in the period of time while the patient was on Campath-1H, the patient will be removed from the study.
• If it is determined that the patient has achieved a complete remission after 6 weeks of Campath-1H treatment a bone marrow biopsy will be performed to confirm complete remission and the patient will not receive any additional treatment but will be followed for a period of 2 years.
• If the disease has remained stable or partial response has been achieved the patient will enter the second phase of therapy in which they will receive an additional 6 weeks of Campath-1H therapy. The patient will then be reassessed as described above.
• No additional therapy (as part of this study) will be performed after a 12 week course of Campath-1H.
• While the patient is on Campath-1H blood test will be performed at 3-6 month intervals over a period extending for 2 years following the last treatment. Bone marrow biopsies and/or aspirations will be conducted as necessary.

Inclusion Criteria:

• Diagnosis of lymphoplasmacytic lymphoma including patients with Waldenstrom's macroglobulinemia
• Adequate organ function: ANC > 500/ul; PLT > 25,000/ul; serum creatinine < 2.5; serum total bilirubin and SGOT < 2.5 times the upper normal limit.
• Age greater than 18 years
• Life expectancy of 6 months or greater
• ECOG performance status of 0-2

Exclusion Criteria:

• Chemotherapy, steroid therapy, or radiation therapy within 21 days of study entry.
• Prior Campath-1H or monoclonal antibody therapy within 3 months of study entry.
• Pregnant women
• Serious co-morbid disease, uncontrolled bacterial, fungal, or viral infection.