NCT00886496

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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2006

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

June 20, 2012

Status Verified

August 1, 2007

First QC Date

April 21, 2009

Last Update Submit

June 19, 2012

Conditions

Fever, Sweats, and Hot FlashesInfectionLeukemiaLymphomaMyelodysplastic SyndromesNeutropeniaUnspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specificfever, sweats, and hot flashesneutropeniainfectionrecurrent childhood small noncleaved cell lymphomastage I and II childhood small noncleaved cell lymphomastage I childhood small noncleaved cell lymphomastage II childhood small noncleaved cell lymphomastage III and IV childhood small noncleaved cell lymphomastage III childhood small noncleaved cell lymphomastage IV childhood small noncleaved cell lymphomarecurrent childhood lymphoblastic lymphomastage I and II childhood lymphoblastic lymphomastage I childhood lymphoblastic lymphomastage II childhood lymphoblastic lymphomastage III and IV childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomachildhood Burkitt lymphomarecurrent/refractory childhood Hodgkin lymphomastage I childhood Hodgkin lymphomastage II childhood Hodgkin lymphomastage III childhood Hodgkin lymphomastage IV childhood Hodgkin lymphomachildhood acute lymphoblastic leukemia in remissionrecurrent childhood acute lymphoblastic leukemiauntreated childhood acute lymphoblastic leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromeschildhood acute myeloid leukemia in remissionrecurrent childhood acute myeloid leukemiauntreated childhood acute myeloid leukemia and other myeloid malignancieschildhood grade III lymphomatoid granulomatosischildhood nasal type extranodal NK/T-cell lymphomarecurrent childhood grade III lymphomatoid granulomatosischildhood diffuse large cell lymphomachildhood immunoblastic large cell lymphomarecurrent childhood large cell lymphomastage I childhood large cell lymphomastage II childhood large cell lymphomastage III and IV childhood large cell lymphomastage III childhood large cell lymphomastage IV childhood large cell lymphoma

Outcome Measures

Primary Outcomes (3)

  • Toxicity

  • Pharmacokinetics

  • Efficacy

Interventions

recombinant human mannose-binding lectinBIOLOGICAL

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

FeverHot FlashesInfectionsLeukemiaLymphomaMyelodysplastic SyndromesNeutropeniaBurkitt LymphomaRecurrencePrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Extranodal NK-T-CellLymphoma, Large B-Cell, DiffuseDendritic Cell Sarcoma, Interdigitating

Interventions

Mannose-Binding Lectin

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinDisease AttributesPathologic ProcessesLeukemia, LymphoidLymphoma, T-CellHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

CollectinsLectins, C-TypeLectinsProteinsAmino Acids, Peptides, and ProteinsMannose-Binding Lectins

Study Officials

  • Thomas J. Walsh, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 23, 2009

Study Start

November 1, 2006

Study Completion

April 1, 2011

Last Updated

June 20, 2012

Record last verified: 2007-08

Locations

US(3)