Campath-1H for Treating Adult T-Cell Leukemia/Lymphoma

Inclusion Criteria: Patients must have serum antibodies directed to Human T-lymphotropic Virus Type 1 (HTLV-1). All patients must have a histologically confirmed diagnosis of adult T- cell leukemia/lymphoma and more than 10% of the malignant cells must express CD52 and CD25. All stages of Tac-expressing adult T-cell leukemia except smoldering are eligible: patients with chronic, lymphoma or acute Acute T-cell leukemia/lymphoma (ATL) are eligible. Patients must have measurable disease. All patients with greater than 10% abnormal (i.e. Tac homogeneous strongly expressing) peripheral blood mononuclear cell (PBMC)in the peripheral blood will be deemed to have measurable disease. The patient must have a granulocyte count of at least 100/mm(3) and a platelet count of greater than or equal to 50,000/mm(3). Patients must have a creatinine of less than 3.0 mg/dl. Omission of cytotoxic chemotherapy for ATL for 3 weeks prior to entry into the trial is required. However patients receiving a stable dose of corticosteroids for at least three to four weeks without evidence of tumor response will be eligible. Patients must have a life expectancy of greater than 2 months. Eligible patients must be greater than or equal to 18 years old. There is no upper age limit. Patients must have serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) value less than or equal to 2.5-fold greater than the upper limit of normal and bilirubin less than or equal to 3.0/dl. If a liver function test is judged to be elevated due to the underlying ATL, this parameter will be considered an unevaluable parameter for toxicity determinations. Patients must be able to understand and sign an Informed Consent form. All patients must use adequate contraception during participation in this trial and for three months after completing therapy. Exclusion Criteria: Patients with symptomatic leukemic meningitis will be excluded. However patients that have both ATL and another HTLV-1-associated disease, tropical spastic paraparesis (TSP) will be included. Pregnant and nursing patients are not eligible for the study. Because the effects of CAMPATH-1H on the developing fetus are unknown pregnant women will be excluded. Breast-feeding in patients with HTLV-1 infection is contraindicated because of the risk of transmission of the virus to the child. In addition, CAMPATH-1H may be present in breast milk and produce adverse events in the breast-feeding child. Human immunodeficiency virus (HIV) positive patients are excluded from the study. CAMPATH-1H may produce a different pattern of toxicities in patients with HIV infection and in addition the depletion of T cells produced by CAMPATH-1H may have adverse effects on HIV positive individuals. Patients with smoldering ATL are excluded. Patients with previously received Campath-1GH are ineligible.