NCT00003883

Brief Summary

RATIONALE: Giving itraconazole or fluconazole may be effective in preventing infections in patients undergoing peripheral stem cell or bone marrow transplantation. It is not yet known whether itraconazole is more effective than fluconazole for preventing infections. PURPOSE: Randomized phase III trial to compare the effectiveness of itraconazole with fluconazole to prevent infections in patients undergoing peripheral stem cell or bone marrow transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
578

participants targeted

Target at P75+ for phase_3 cancer

Timeline
Completed

Started Oct 1998

Typical duration for phase_3 cancer

Geographic Reach
1 country

2 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

October 1, 1998

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

March 31, 2004

Completed
Last Updated

April 2, 2010

Status Verified

March 1, 2010

Enrollment Period

3.8 years

First QC Date

November 1, 1999

Last Update Submit

March 31, 2010

Conditions

Cancer

Keywords

stage IV breast cancerstage IIIA breast cancerstage IIIB breast cancerrecurrent childhood acute lymphoblastic leukemiarecurrent adult Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarefractory multiple myelomarecurrent childhood rhabdomyosarcomastage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerdisseminated neuroblastomarecurrent neuroblastomarecurrent Wilms tumor and other childhood kidney tumorsstage I multiple myelomastage II multiple myelomastage III multiple myelomarecurrent childhood lymphoblastic lymphomastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiastage III malignant testicular germ cell tumorrecurrent malignant testicular germ cell tumorchronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiachronic idiopathic myelofibrosischildhood acute promyelocytic leukemia (M3)testicular embryonal carcinomatesticular choriocarcinomatesticular teratomatesticular yolk sac tumortesticular embryonal carcinoma and teratomatesticular embryonal carcinoma and teratoma with seminomatesticular embryonal carcinoma and yolk sac tumortesticular embryonal carcinoma and yolk sac tumor with seminomatesticular embryonal carcinoma and seminomatesticular yolk sac tumor and teratomatesticular yolk sac tumor and teratoma with seminomatesticular choriocarcinoma and yolk sac tumortesticular choriocarcinoma and embryonal carcinomatesticular choriocarcinoma and teratomatesticular choriocarcinoma and seminomarefractory hairy cell leukemiarecurrent/refractory childhood Hodgkin lymphomarecurrent ovarian germ cell tumorovarian yolk sac tumorovarian embryonal carcinomaovarian polyembryomaovarian choriocarcinomaovarian immature teratomaovarian mature teratomaovarian monodermal and highly specialized teratomaovarian mixed germ cell tumorstage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomasecondary acute myeloid leukemiade novo myelodysplastic syndromespoor prognosis metastatic gestational trophoblastic tumorpreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesinfectionrecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult lymphoblastic lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomapreviously treated childhood rhabdomyosarcomarecurrent mycosis fungoides/Sezary syndromenoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomachildhood myelodysplastic syndromes

Interventions

fluconazoleDRUG
itraconazoleDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Scheduled to undergo allogeneic peripheral blood stem cell, bone marrow, or cord blood transplant (except minitransplant) No documented or suspected invasive fungal infection PATIENT CHARACTERISTICS: Age: 13 and over Performance status: Not specified Life expectancy: More than 2 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 5 times upper limit of normal (ULN) OR AST or ALT no greater than 5 times ULN OR Alkaline phosphatase no greater than 5 times ULN Renal: Not specified Other: Weight at least 40 kg Fertile patients must use effective contraception No history of anaphylaxis due to azole antifungal drug compounds No uncontrolled bacteremia No concurrent condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior nonmyeloablative regimen (e.g., FHCRC-1209 or FHCRC-1225) No other concurrent antifungal agents No concurrent astemizole, terfenadine, or cisapride

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

Sponsors & Collaborators

Study Sites (2)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

MeSH Terms

Conditions

NeoplasmsBreast NeoplasmsPrecursor Cell Lymphoblastic Leukemia-LymphomaHodgkin DiseaseLymphoma, T-Cell, CutaneousMultiple MyelomaCarcinoma, Ovarian EpithelialNeuroblastomaWilms TumorLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcuteTesticular NeoplasmsLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisPrimary MyelofibrosisTeratoma, TesticularEndodermal Sinus TumorTeratomaSeminomaCarcinoma, EmbryonalLeukemia, Hairy CellRecurrenceLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaInfectionsDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal Zone

Interventions

FluconazoleItraconazole

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphomaLymphoma, T-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersCarcinomaNeoplasms, Glandular and EpithelialOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeoplasms, Complex and MixedKidney NeoplasmsUrologic NeoplasmsNeoplastic Syndromes, HereditaryKidney DiseasesUrologic DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, MyeloidGenital Neoplasms, MaleGenital Diseases, MaleTesticular DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersBone Marrow DiseasesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMesonephromaGerminomaLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Kieren A. Marr, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 31, 2004

Study Start

October 1, 1998

Primary Completion

July 1, 2002

Study Completion

July 1, 2002

Last Updated

April 2, 2010

Record last verified: 2010-03

Locations

US(2)