INCLUSION CRITERIA:
Patient age: greater than or equal to 6 months and less than 18 years.
Histologic diagnosis: All patients must have a histologically confirmed diagnosis of one of the following:
Non-Hodgkin's lymphoma (NHL) including lymphoblastic lymphoma, Burkitt's lymphoma, large cell lymphoma, adult T-cell leukemia/lymphoma (ATL), cutaneous T-cell lymphoma (CTCL), peripheral T-cell lymphoma (PTCL);
Hodgkin's disease (HD);
Acute myelogenous leukemia (AML);
Chronic myelogenous leukemia (CML);
Acute lymphoblastic leukemia (ALL);
Acute hybrid leukemia (including mixed lineage, biphenotypic, and undifferentiated).
CD25 expression: Patients must have evidence of CD25 positivity by at least one of the following criteria:
Greater than 15% of malignant cells from a site react with anti-CD25 by immunohistochemistry;
30% of malignant cells from a site are CD25+ by FACS analysis.
Stage of Disease and Prior Therapy:
Patients must have measurable or evaluable disease.
Patients must have relapsed or refractory disease after at least one standard chemotherapy and one salvage regimen. Patients with acute leukemia must have greater than 25% blasts in the bone marrow (i.e., M3 marrow classification).
In the view of the PI and the primary oncologist, there must be no available alternative curative therapies and patients must either be ineligible for hematopoietic stem cell transplant (BMT), have refused BMT, or have disease activity that prohibits the time required to identify a suitable stem cell donor.
Relapse after prior autologous or allogeneic BMT is allowed. In the event of relapse after prior allogeneic BMT, the patient must be at least day +100 post-transplant.
Patients must have had their last doses of chemotherapy at least 3 weeks (4 weeks for nitrosoureas) prior to study entry. Patients must have had their last doses of radiation therapy at least 3 weeks prior to study entry with the following exception: Patients who have received or are receiving radiation therapy less than 3 weeks prior to study entry will not be excluded providing the volume of bone marrow treated is less than 10% and the patient has measurable disease outside the radiation port.
Patients must have recovered from the acute toxic effects of all prior therapy before entry.
Patients should be off colony stimulating factors (e.g., G-CSF, GM-CSF, EPO) for at least one week prior to entry.
Patients receiving corticosteroids are allowed provided there has been no change in dose for at least 2 weeks prior to study entry.
Patients should be off other investigational agents for at least 30 days prior to entry.
Performance Status:
Patients greater than or equal to 12 years of age: ECOG score of 0, 1, or 2.
Patients less than 12 years of age: Lansky scale greater than or equal to 50%.
Patients who are unable to walk because of paralysis, but who are up in a wheel chair will be considered ambulatory for the purpose of calculating the performance score.
Hematological function: A patient will not be excluded because of pancytopenia due to disease based on bone marrow analysis. For patients without bone marrow involvement, the absolute neutrophil count (ANC) must be greater than 1000/mm(3) and the platelet count greater than 50,000/mm(3) independent of transfusion.
Hepatic function: Less than or equal to Grade 1 NCI Common Toxicity Criteria as follows: total bilirubin less than or equal to 1.5 x the upper limit of normal (less than or equal to 1.5 mg/dl) and transaminases less than or equal to 2.5 x the upper limit of normal (ALT less than or equal to 103 U/L, AST less than or equal to 85 U/L).
Renal function: Patients must have an age-adjusted normal serum creatinine (see below) OR a creatinine clearance greater than or equal to 60 mL/min/1.73 m(2):
Age (Years): Less than or equal to 5
Maximum Serum Creatinine (mg/dl): 0.8
Age (Years): 5 less than age less than or equal to 10
Maximum Serum Creatinine (mg/dl): 1.0
Age (Years): 10 less than age less than or equal to 15
Maximum Serum Creatinine (mg/dl): 1.2
Age (Years): greater than 15
Maximum Serum Creatinine (mg/dl): 1.5
Cardiac function: Left ventricular function must be normal (ejection fraction greater than or equal to 45% by MUGA or shortening fraction greater than or equal to 28% by ECHO).
Respiratory function: Oxygen saturation greater than or equal to 90%.
Patients with childbearing potential are required to practice contraception during the study.
As patients will be less than 18 years old their legal guardian must give informed consent.
Serum electrolytes: Less than or equal to Grade I NCI Common Toxicity Criteria as follows: sodium 130-150 mmol/L, potassium 3.0-5.5 mmol/L, calcium 2.0-2.9 mmol/L, magnesium 0.5-1.23 mmol/L (chronic oral supplementation to maintain normal levels allowed).
EXCLUSION CRITERIA:
CNS leukemia or lymphoma as manifested by any of the following:
CSF WBC greater than 5/micro l and confirmation of CSF blasts.
Cranial neuropathies deemed secondary to underlying malignancy.
Radiologically detected CNS lymphoma.
History of CNS involvement with no current evidence of CNS malignancy is NOT an exclusion.
Isolated testicular ALL.
Clinically significant unrelated systemic illness that in the judgment of the PI would likely compromise the patient's ability to tolerate this therapy or interfere with the study procedures.
Patients whose serum neutralizes greater than 75% of the activity of 1 micro g/mL of LMB-2 in tissue culture, due to either anti-toxin or anti-mouse-IgG antibodies.
HIV infection (due to increased risk of severe infection and unknown interaction of LMB-2 with antiretroviral agents).
Active hepatitis B or C infection as defined by seropositive for hepatitis B (HbSAg) or hepatitis C and elevated liver transaminases.
Patients currently receiving other investigational agents.
Lactating or pregnant females (due to unknown risk to fetus or nursing child).
High risk of inability to comply with protocol treatment as determined by PI, social work, and primary oncologist.
Patients who require anticoagulation for disease-related conditions.
Warren Grant Magnuson Clinical Center (CC)