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

Inclusion Criteria

• •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