Protocol Number: 07-C-0027
-Infections are a major cause of sickness and death in children with cancer. -Studies show that a protein called mannose-binding lectin (MBL) is important in immunity and that changes in blood levels of MBL are associated with serious infectious complications when the immune system is stressed. -A new genetically engineered MBL protein called rhMBL may be useful in treating some patients with low MBL levels. Objectives: -To determine the pharmacokinetics, safety and tolerability of rhMBL in children with cancer and examine how the body handles the drug. -To see if rhMBL helps to control infections in children with cancer. Eligibility: -Children ages 2 to 17 who are receiving cancer chemotherapy, who have low MBL levels and low neutrophil (type of white blood cell) count and fever (temperature over 100.4 F). Design: -Patients receive a one-time dose of recombinant rhMBL through a central line or IV within three days after developing a fever and low neutrophil count. -The first group of children entering the study receives a dose of 0.5 mg/kg; the second group receives a dose of 1 mg/kg. Both dosages are infused over 60 minutes. -Patients have small amounts of blood drawn over the duration of the 4-week study to measure the levels of MBL in the blood, look for possible changes in the immune system and check for any side effects of rhMBL. -Patients also receive standard antibiotics used to treat and prevent infections during fever and neutropenia occurring after chemotherapy.
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