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Recombinant Human Mannose-Binding Lectin (MBL) in Treating Young Patients With MBL Deficiency and Fever and Neutropenia - NCT00886496-19104(Clinical Trial 288380)



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City:  Philadelphia
State:  
PA
Zip Code: 19104
Conditions: Fever, Sweats, and Hot Flashes - Infection - Leukemia - Lymphoma - Myelodysplastic Syndromes - Neutropenia - Unspecified Childhood Solid Tumor, Protocol Specific
Purpose: 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.
Study summary: OBJECTIVES: Primary - Determine the safety and tolerability of recombinant human mannose-binding lectin (MBL) in pediatric patients with MBL deficiency and fever and neutropenia who are undergoing cytotoxic chemotherapy for hematological/oncological disease. - Determine the pharmacokinetics of this drug in these patients. Secondary - Determine the pharmacodynamic effect of this drug in these patients. - Determine nonspecific activation of complement by in vivo determination of C3d complement activation in patients treated with this drug. - Determine the ex-vivo activity of recombinant MBL in opsonization capacity of patients' sera to yeast and bacteria. - Determine immunogenicity of this drug in these patients. - Determine the incidence and duration of fever and breakthrough infections in patients treated with this drug. OUTLINE: This is a non-randomized, multicenter, open-label, prospective, cohort study. Patients are assigned to 1 of 2 treatment groups. - Group I: Patients receive low-dose recombinant human mannose-binding lectin (MBL) IV over 1 hour within 72 hours of onset of fever and neutropenia. - Group II: Patients receive high-dose recombinant human MBL IV over 1 hour within 72 hours of onset of fever and neutropenia. Patients undergo blood collection periodically during study for pharmacokinetic, pharmacodynamic, MBL immunogenicity, and opsonization/phagocytosis studies. After completion of study treatment, patients are followed for 30 days. PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
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
Study is available at: Children's Hospital of Philadelphia
Philadelphia, PA 19104
United States

Primary Contact:
Theoklis Zaoutis, MD
Email: zaoutis@email.chop.edu
Phone: 215-590-1000
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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