LMB-2 Immunotoxin in Treating Young Patients With Relapsed or Refractory Leukemia or Lymphoma

Inclusion Criteria

• •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