Recombinant Human Mannose-Binding Lectin (MBL) in Treating Young Patients With MBL Deficiency and Fever and Neutropenia

This is an interventional supportive care trial for Fever, Sweats, and Hot Flashes focused on measuring unspecified childhood solid tumor, protocol specific, fever, sweats, and hot flashes, neutropenia, infection, recurrent childhood small noncleaved cell lymphoma, stage I and II childhood small noncleaved cell lymphoma, stage I childhood small noncleaved cell lymphoma, stage II childhood small noncleaved cell lymphoma, stage III and IV childhood small noncleaved cell lymphoma, stage III childhood small noncleaved cell lymphoma, stage IV childhood small noncleaved cell lymphoma, recurrent childhood lymphoblastic lymphoma, stage I and II childhood lymphoblastic lymphoma, stage I childhood lymphoblastic lymphoma, stage II childhood lymphoblastic lymphoma, stage III and IV childhood lymphoblastic lymphoma, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, childhood Burkitt lymphoma, recurrent/refractory childhood Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage II childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, childhood acute lymphoblastic leukemia in remission, recurrent childhood acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies, childhood grade III lymphomatoid granulomatosis, childhood nasal type extranodal NK/T-cell lymphoma, recurrent childhood grade III lymphomatoid granulomatosis, childhood diffuse large cell lymphoma, childhood immunoblastic large cell lymphoma, recurrent childhood large cell lymphoma, stage I childhood large cell lymphoma, stage II childhood large cell lymphoma, stage III and IV childhood large cell lymphoma, stage III childhood large cell lymphoma, stage IV childhood large cell lymphoma Read More

DISEASE CHARACTERISTICS:

• Undergoing cytologic chemotherapy for hematological/oncological disease

• Must meet all of the following criteria:

  • Documented mannose-binding lectin (MBL) levels < 300 ng/mm³ within the past week
  • Fever (oral temperature > 100.4° F)
  • Neutropenia, defined as absolute neutrophil count ≤ 1,000/mm³ with the anticipation that the counts will fall below 500/mm^3
  • Receiving broad spectrum antibiotic therapy for fever and neutropenia

PATIENT CHARACTERISTICS:

• No serious illness, in the opinion of the principal investigator, that would preclude study compliance
• No known allergic reactions to mannose-binding lectin or other human plasma products
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier method contraception during and for ≥ 30 days after completion of study treatment
• AST and ALT ≤ 5 times upper limit of normal (ULN)
• Bilirubin ≤ 2.5 times ULN

• Creatinine clearance > 60 mL/min OR creatinine based on age as follows:

  • No more than 0.8 mg/dL (for patients 5 years of age and under)
  • No more than 1.0 mg/dL (for patients 6-9 years of age)
  • No more than 1.2 mg/dL (for patients 10-12 years of age)
  • No more than 1.4 mg/dL (for patients over 13 years of age [female])
  • No more than 1.5 mg/dL (for patients 13-15 years of age [male])
  • No more than 1.7 mg/dL (for patients of 16 years of age [male])
• No poor venous access that would preclude IV drug delivery or multiple blood draws
• Patients on hemodialysis must be able to tolerate IV fluid on non-dialysis days

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 30 days since prior investigational agents

  • Investigational use of an FDA-approved drug allowed
• No concurrent preparative regimen for a bone marrow or hematopoietic stem cell transplantation
• No concurrent participation in another clinical trial with an investigational agent