Recombinant Human Mannose-Binding Lectin (MBL) in Treating Young Patients With MBL Deficiency and Fever and Neutropenia - NCT00886496-92868 (Clinical Trial 288378)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy288378.aspx
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| City: |
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Orange |
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State:
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CA |
| Zip Code: |
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92868 |
| Conditions: |
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Fever, Sweats, and Hot Flashes - Infection - Leukemia - Lymphoma - Myelodysplastic Syndromes - Neutropenia - Unspecified Childhood Solid Tumor, Protocol Specific |
| Purpose: |
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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.
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| Study summary: |
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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: |
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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 |
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| Study is available at: |
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Children's Hospital of Orange County
Orange, CA 92868
United States
Primary Contact:
Antonio Arrieta, MD
Phone: 714-532-8403 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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