Anti-Tac for Treatment of Leukemia

Inclusion Criteria

• •ELIGIBILITY CRITERIA:
• •Population Base.
• •Patients diagnosed with smoldering or chronic human T-lymphotropic virus type 1 (HTLV-I)- associated adult T-cell leukemia.
• •Patients must have serum antibodies directed to HTLV-I.
• •All patients must have a histologically confirmed diagnosis of adult T-cell leukemia/lymphoma.
• •At least 5 percent of each patient's peripheral blood, lymph node, pulmonary or dermal malignant cells must react with the anti-Tac mAb as determined by immunofluorescent staining or, alternatively, the serum-soluble interleukin 2 (IL-2) receptor levels must be greater than 1,000 units/ml (normal geometric mean, 235; with a 95% confidence interval of 112 to 502 units/mL).
• •Smoldering or chronic stage Tac-expressing adult T-cell leukemia defined by the Shimomyama Criteria (37) are eligible.
• •To be diagnosed as smoldering Adult T-cell Leukemia (ATL), the patient must have a normal lymphocyte count (less than 4 times 10\^3/mm\^3), less than or equal to 5 percent abnormal lymphocytes on morphologic examination of the peripheral blood smear or on fluorescence activated cell sorting (FACS) analysis (cells with a homogenous staining pattern and a greater than 1 log increase in the magnitude of fluorescence emission of the anti-Tac peak over background expression),
• •no hypercalcemia,
• •lactate dehydrogenase less than or equal to 1.5 times the upper limit of normal,
• •no lymphadenopathy,
• •no involvement of extra nodal organs except skin or lung and no malignant pleural effusion or ascites.
• •If the abnormal lymphocyte count is less than 5 percent, the patient must have at least one histologically proven skin ATL lesion to be diagnosed as smoldering ATL.
• •Patients with \>5% of circulating lymphocytes that are abnormal are considered to have measurable disease.
• •The patient must have a granulocyte count of at least 500/mm\^3 and a platelet count of 25,000/mm\^3.
• •Patients must have a creatinine of less than 3.0 mg/dl.
• •Patients must have a Karnofsky performance score of greater than 60 percent.
• •ATL patients without, as well as those with, previous chemotherapy will be eligible for inclusion in the study.
• •Patients with previous therapy with a monoclonal antibody including anti-Tac will be eligible for the study provided that they do not have a positive HAHA (human antibody to humanized anti-Tac) value (i.e., such patients must have a value greater than 250 ng/ml).
• •Omission of cytotoxic chemotherapy for ATL for 3 weeks prior to entry into the trial is required.
• •However, patients receiving corticosteroids will not be excluded.
• •Patients must have a life expectancy of greater than 2 months.
• •Eligible patients must be greater than or equal to 10 years old.
• •There is no upper age limit.
• •Patients over the age of 18 years must be able to understand and sign an Informed Consent form.
• •Eligible minors greater than or equal to 10 years old must give assent to participate in this study.