Monoclonal Antibody Therapy in Treating Patients With Leukemia
Lymphoma, Radiation Toxicity
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, recurrent adult T-cell leukemia/lymphoma, radiation toxicity
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adult T-cell leukemia or lymphoma (ATL) of any stage Tac expression of malignant cells confirmed by one of the following: At least 10% of peripheral blood, lymph node, or dermal malignant cells reactive with anti-Tac by immunofluorescent staining Soluble interleukin-2 receptor levels greater than 1,000 U/mL (normal geometric mean = 235; 95% confidence intervals = 112-502 U/mL) Measurable disease required More than 10% (i.e., strongly Tac-expressing) abnormal cells in peripheral blood considered measurable disease All stages of Tac-expressing adult T-cell leukemia are eligible Smoldering ATL patients are eligible only if the symptoms and sites of involvement by ATL are such that there is a medical indication to treat Smoldering ATL, defined as: Lymphocyte count less than 4,000/mm^3 Less than 5% abnormal lymphocytes on morphologic exam of peripheral blood No hypercalcemia Lactate dehydrogenase no greater than 1.5 times normal No lymphadenopathy No involvement of extranodal organs except skin or lung No malignant pleural effusion or ascites No symptomatic CNS disease due to ATL Concurrent diagnosis of tropical spastic paraparesis allowed No detectable levels (i.e., greater than 250 ng/mL) of antibody to study drug as assessed by ELISA PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Greater than 2 months Hematopoietic: Absolute granulocyte count at least 1,000/mm^3 Platelet count at least 75,000/mm^3 Hepatic: Bilirubin less than 2.0 mg/dL (unless directly due to ATL) AST/ALT less than 2.5 times normal Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 35 mL/min Cardiovascular: No clinical cardiac failure Pulmonary: No symptomatic pulmonary dysfunction unless due to underlying malignancy Other: HIV negative Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 4 weeks since prior cytotoxic chemotherapy Endocrine therapy Concurrent corticosteroids allowed Radiotherapy Not specified Surgery Not specified Other Not specified
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support