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

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