A Multi-Center Study of the Safety, Tolerability, Pharmacokinetics and Dose Escalation of Intravenous Recombinant Human Mannose-Binding-Lectin (rhMBL) in MBL Deficient Pediatric Hematology/Oncology Patients With Fever and Neutropenia

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

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety