NCT00066599

Brief Summary

RATIONALE: Voriconazole may be effective in preventing systemic fungal infections following chemotherapy. PURPOSE: Phase II trial to study the effectiveness of voriconazole in preventing systemic fungal infections in children who have neutropenia after receiving chemotherapy for leukemia, lymphoma, or aplastic anemia or in preparation for bone marrow or stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

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

June 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

June 19, 2013

Status Verified

July 1, 2004

First QC Date

August 6, 2003

Last Update Submit

June 18, 2013

Conditions

Kidney CancerLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsNeuroblastomaNeutropeniaSarcoma

Keywords

neutropeniarecurrent childhood lymphoblastic lymphomastage I childhood lymphoblastic lymphomastage II childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomastage I childhood small noncleaved cell lymphomastage II childhood small noncleaved cell lymphomastage III childhood small noncleaved cell lymphomastage IV childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomastage I childhood large cell lymphomastage II childhood large cell lymphomastage III childhood large cell lymphomastage IV childhood large cell lymphomachildhood acute myeloid leukemia in remissionrecurrent childhood acute myeloid leukemiauntreated childhood acute myeloid leukemia and other myeloid malignanciesrecurrent/refractory childhood Hodgkin lymphomastage I childhood Hodgkin lymphomastage II childhood Hodgkin lymphomastage III childhood Hodgkin lymphomastage IV childhood Hodgkin lymphomachildhood acute promyelocytic leukemia (M3)previously treated childhood rhabdomyosarcomarecurrent Wilms tumor and other childhood kidney tumorsrecurrent childhood rhabdomyosarcomachildhood chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachronic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiarelapsing chronic myelogenous leukemiaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomaintraocular lymphomaprimary central nervous system non-Hodgkin lymphomarecurrent adult T-cell leukemia/lymphomaacute undifferentiated leukemiachildhood acute lymphoblastic leukemia in remissionrecurrent childhood acute lymphoblastic leukemiasecondary acute myeloid leukemiauntreated childhood acute lymphoblastic leukemiadisseminated neuroblastomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesstage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myelomastage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent neuroblastomaatypical chronic myeloid leukemia, BCR-ABL1 negativemyelodysplastic/myeloproliferative neoplasm, unclassifiable

Interventions

voriconazoleDRUG

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
DISEASE CHARACTERISTICS: * Expected to develop neutropenia (absolute neutrophil count less than 500/mm\^3) lasting for more than 10 days after chemotherapy for 1 of the following conditions: * Leukemia * Lymphoma * Aplastic anemia * Preparation for a bone marrow or stem cell transplantation * Requiring treatment for the prevention of systemic fungal infection PATIENT CHARACTERISTICS: Age * 2 to 11 Performance status * Not specified Life expectancy * More than 3 months Hematopoietic * See Disease Characteristics Hepatic * AST and ALT no greater than 5 times upper limit of normal (ULN) * Bilirubin no greater than 5 times ULN Renal * Creatinine clearance at least 30 mL/min Cardiovascular * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * No severe hypokalemia (potassium less than 3.2 mmol/L) * No prior hypersensitivity to or severe intolerance of azole antifungal agents * No other concurrent condition that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 24 hours since prior use of any of the following: * Terfenadine * Pimozide * Quinidine * Astemizole * Cisapride * Omeprazole * More than 14 days since prior use of any of the following: * Rifampin * Rifabutin * Carbamazepine * Phenytoin * Nevirapine * Long-acting barbiturates * No prior sirolimus * No prior enrollment on this study * No concurrent use of any of the following: * Terfenadine * Pimozide * Quinidine * Astemizole * Cisapride * Omeprazole * No other concurrent investigational drugs except any of the following: * Drugs used as treatment for cancer * Antiretroviral agents * Drugs used for the treatment of any AIDS-defining opportunistic infections * No concurrent enrollment in investigational anticancer drug trials that exclude the use of other investigational agents

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

Sponsors & Collaborators

Study Sites (7)

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Children's Hospital and Health Center, San Diego

San Diego, California, 92123-4282, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4318, United States

Location

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesNeuroblastomaNeutropeniaSarcomaBurkitt LymphomaDendritic Cell Sarcoma, InterdigitatingRecurrenceWilms TumorLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myeloid, Chronic-PhaseLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyIntraocular LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Biphenotypic, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative Disorders

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersNeoplasms, Connective and Soft TissueEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinHistiocytic Disorders, MalignantHistiocytosisDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Complex and MixedNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, T-CellLymphadenopathyEye NeoplasmsLeukemia, Lymphoid

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Thomas J. Walsh, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
NIH

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

June 1, 2003

Study Completion

June 1, 2004

Last Updated

June 19, 2013

Record last verified: 2004-07

Locations

US(7)