Pediatric Phase I Trial of LMB-2 for Refractory CD25-Positive Leukemias and Lymphomas

Date de début de l'étude : 1 avril 2004

DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Non-Hodgkin's lymphoma, including the following subtypes: * Lymphoblastic lymphoma * Burkitt's lymphoma * Large cell lymphoma * Adult T-cell leukemia/lymphoma * Cutaneous T-cell lymphoma * Peripheral T-cell lymphoma * Hodgkin's disease * Acute myeloid leukemia * Chronic myelogenous leukemia * Acute lymphoblastic leukemia (ALL) * More than 5% blasts in the bone marrow (i.e., M2 marrow classification) * Acute hybrid leukemia, including the following subtypes: * Mixed lineage leukemia * Biphenotypic leukemia * Undifferentiated leukemia * CD25-positive (CD25+) disease, meeting 1 of the following criteria: * More than 15% of malignant cells are CD25+ by immunohistochemistry with anti-CD25 antibody * More than 30% of malignant cells from a site are CD25+ by fluorescence-activated cell sorting analysis * Measurable or evaluable disease * Relapsed or refractory disease after at least 1 standard chemotherapy regimen AND 1 salvage regimen * No available alternative curative therapies * Ineligible for or refused hematopoietic stem cell transplantation OR disease activity that prohibits the required time to identify a suitable stem cell donor * No CNS leukemia or lymphoma, as evidenced by any of the following criteria: * Cerebrospinal fluid (CSF) WBC \> 5/µl AND confirmation of CSF blasts * Cranial neuropathies secondary to underlying malignancy * CNS lymphoma detected by radiological imaging * Prior CNS involvement with no current evidence of CNS malignancy allowed * No isolated testicular ALL PATIENT CHARACTERISTICS: Age * 6 months to 21 years Performance status * ECOG 0-3 (≥ 12 years of age) * Lansky 40-100% (\< 12 years of age) Life expectancy * Not specified Hematopoietic * Pancytopenia due to disease allowed * For patients without bone marrow involvement: * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 50,000/mm\^3 (transfusion independent) Hepatic * Bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 5 times upper limit of normal * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine clearance ≥ 60 mL/min OR * Creatinine, meeting the following age-related criteria: * ≤ 0.8 mg/dL (≤ 5 years of age) * ≤ 1.0 mg/dL (6 to 10 years of age) * ≤ 1.2 mg/dL (11 to 15 years of age) * ≤ 1.5 mg/dL (\> 15 years of age) * Calcium 2.0-2.9 mmol/L Cardiovascular * Ejection fraction ≥ 45% by MUGA OR * Shortening fraction ≥ 28% by echocardiogram Pulmonary * Oxygen saturation ≥ 90% Other * Sodium 130-150 mmol/L * Potassium 3.0-5.5 mmol/L * Magnesium 0.5-1.23 mmol/L * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No clinically significant unrelated systemic illness that would preclude study participation * No conditions that would preclude study compliance * No serum that neutralizes \> 75% of the activity of 1 μg/mL of LMB-2 immunotoxin in tissue culture (due to either anti-toxin or anti-mouse immunoglobulin G antibodies) * No active graft-vs-host disease (i.e., off immunosuppression) PRIOR CONCURRENT THERAPY: Biologic therapy * Prior autologous bone marrow transplantation (BMT) allowed * At least 100 days since prior allogeneic BMT * At least 1 week since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa) Chemotherapy * At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) except intrathecal chemotherapy * No other concurrent chemotherapy Endocrine therapy * Concurrent corticosteroids allowed provided the dose has been stable for the past week and does not increase during study treatment * Tapering or discontinuation of steroids allowed Radiotherapy * At least 3 weeks since prior radiotherapy unless \< 10% of marrow is irradiated and measurable disease exists outside the radiation port Surgery * Not specified Other * Recovered from all prior therapy * At least 30 days since prior investigational agents * Concurrent oral supplementation to maintain normal electrolyte levels allowed * No concurrent anticoagulation therapy for disease-related conditions * No other concurrent investigational agents