Recombinant Human Mannose-Binding Lectin (MBL) in Treating Young Patients With MBL Deficiency and… (NCT00886496) | Clinical Trial Compass
WithdrawnPhase 1
Recombinant Human Mannose-Binding Lectin (MBL) in Treating Young Patients With MBL Deficiency and Fever and Neutropenia
Stopped: No participants enrolled. IND withdrawn.
United States0Started 2006-11
Plain-language summary
RATIONALE: Recombinant human mannose-binding lectin (MBL) may be effective in preventing infection in young patients with fever and neutropenia receiving chemotherapy for blood disease or cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of recombinant human mannose-binding lectin in treating young patients with MBL deficiency and fever and neutropenia.
Who can participate
Age range2 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 multi…