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WITHDRAWN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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Page 1 of 1 (3 locations)

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