Status:
WITHDRAWN
Recombinant Human Mannose-Binding Lectin (MBL) in Treating Young Patients With MBL Deficiency and Fever and Neutropenia
Lead Sponsor:
Enzon Pharmaceuticals, Inc.
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fever, Sweats, and Hot Flashes
Infection
Eligibility:
All Genders
2-17 years
Phase:
PHASE1
Brief 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. PUR...
Detailed Description
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 c...
Eligibility 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00886496
Start Date
November 1 2006
End Date
April 1 2011
Last Update
June 20 2012
Active Locations (3)
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1
Children's Hospital of Orange County
Orange, California, United States, 92868
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010-2970
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104