A Study of Safety, Tolerability, and Pk of rhMBL in Pediatric Hematology/Oncology Pts With Fever and Neutropenia
NCT ID: NCT00520325
Last Updated: 2012-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2007-06-30
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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0.5 mg/kg
Intravenous recombinant human mannose binding lectin
Intravenous(i.v.) administration for one dose. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
1.0 mg/kg
Intravenous recombinant human mannose binding lectin
Intravenous(i.v.) administration for one dose. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
Interventions
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Intravenous recombinant human mannose binding lectin
Intravenous(i.v.) administration for one dose. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
Intravenous recombinant human mannose binding lectin
Intravenous(i.v.) administration for one dose. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
Eligibility Criteria
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Inclusion Criteria
* Patients must have documented MBL levels \<300 ng/mL in serum as evaluated in the screening protocol.
* Fever defined as an oral temperature equivalent of \>100.4°F (38°C).
* Neutropenia defined as an absolute neutrophil count ≤1,000/mm3 with the anticipation that the counts will fall below 500/mm3.
* Receiving broad spectrum antibiotics for fever and neutropenia.
* Patients with age-adjusted normal serum creatinine OR a creatinine clearance \>60 mL/min/1.73m2.
* Informed consent of the patient, parent or legally authorized representative obtained prior to entry.
* Reliable and willing to make themselves available for the duration of the study and to abide by the study restrictions.
Exclusion Criteria
* Concurrent serious illness in the opinion of the principal investigator that could potentially interfere with protocol compliance.
* Patient is pregnant, breast feeding or planning a pregnancy during the course of the study.
* Sexually active male and female patients not using an acceptable barrier method of contraception or practicing abstinence throughout the study and for at least 30 days after receiving their last treatment unless the patient is surgically or medically sterile.
* Patients with moderate or severe liver disease, as defined by:
AST or ALT \>5 times upper limit of normal (ULN) OR Total bilirubin \>2.5 times ULN.
* Patients with poor venous access that would preclude intravenous drug delivery or multiple blood draws.
* Current participation in another clinical study with an investigational agent and/or use of an investigational drug (not including investigational use of an FDA approved drug) in the 30 days before scheduled administration of rhMBL.
* Known allergic reactions to MBL or other human plasma products.
* Patients on hemodialysis unable to tolerate the volume of IV fluid on non-dialysis days.
2 Years
17 Years
ALL
No
Sponsors
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Enzon Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Enzon Pharmaceuticals, Inc
Principal Investigators
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Thomas Walsh, MD
Role: PRINCIPAL_INVESTIGATOR
NIH/National Cancer Institute
Countries
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Other Identifiers
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NCI # 07-C-0027
Identifier Type: -
Identifier Source: secondary_id
EZN-2232-03
Identifier Type: -
Identifier Source: org_study_id