NCT00003938

Brief Summary

RATIONALE: Liposomal amphotericin B may be effective in controlling fever and granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more effective in treating cancer patients who have these conditions. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of liposomal amphotericin B in treating granulocytopenia and fever in cancer patients.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P25-P50 for phase_3 cancer

Geographic Reach
15 countries

24 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, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

3.9 years

First QC Date

November 1, 1999

Last Update Submit

September 20, 2012

Conditions

Cancer

Keywords

stage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomastage IV breast cancerstage IIIA breast cancermonoclonal gammopathy of undetermined significancestage IIIB breast cancerrecurrent childhood acute lymphoblastic leukemiarecurrent adult Hodgkin lymphomastage 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 cutaneous T-cell non-Hodgkin lymphomaisolated plasmacytoma of boneextramedullary plasmacytomarefractory 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 0 chronic lymphocytic leukemiaWaldenstrom macroglobulinemiastage I multiple myelomastage II multiple myelomastage III multiple myelomastage I childhood lymphoblastic lymphomastage II childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomarecurrent childhood lymphoblastic lymphomastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage 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 leukemiasmall intestine lymphomastage III malignant testicular germ cell tumorrecurrent malignant testicular germ cell tumorunspecified childhood solid tumor, protocol specificunspecified adult solid tumor, protocol specificchronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood acute lymphoblastic leukemia in remissionpolycythemia veraprimary myelofibrosisessential thrombocythemiafever, sweats, and hot flasheschildhood 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 seminomaprogressive hairy cell leukemia, initial treatmentrefractory hairy cell leukemiastage II childhood Hodgkin lymphomastage I childhood Hodgkin lymphomastage III childhood Hodgkin lymphomastage IV childhood Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I adult diffuse small cleaved cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse large cell lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I adult Burkitt lymphomarecurrent ovarian germ cell tumorchronic myelomonocytic leukemiaT-cell large granular lymphocyte leukemiaovarian yolk sac tumorovarian embryonal carcinomaovarian polyembryomaovarian choriocarcinomaovarian immature teratomaovarian mature teratomaovarian monodermal and highly specialized teratomaovarian mixed germ cell tumoracute undifferentiated leukemiastage 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 lymphomastage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomade novo myelodysplastic syndromeshigh risk metastatic gestational trophoblastic tumorpreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesprimary central nervous system non-Hodgkin lymphomaneutropeniainfectionpreviously untreated childhood rhabdomyosarcomaprolymphocytic leukemiaprimary systemic amyloidosisintraocular lymphomastage I childhood small noncleaved cell lymphomastage I childhood large cell lymphomastage II childhood small noncleaved cell lymphomastage II childhood large cell lymphomastage III childhood small noncleaved cell lymphomastage III childhood large cell lymphomastage IV childhood small noncleaved cell lymphomastage IV childhood large cell lymphomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomastage I mantle cell lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II mantle cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult Burkitt lymphomacontiguous stage II adult lymphoblastic 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 lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomapreviously treated childhood rhabdomyosarcomastage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromechildhood chronic myelogenous leukemiachronic eosinophilic leukemiachronic neutrophilic leukemiacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage I marginal zone lymphomastage I 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

liposomal amphotericin BDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Hematologic malignancy or solid tumor * Must be undergoing remission induction and/or consolidation therapy for hematologic malignancy only OR * Must be undergoing allogeneic or autologous bone marrow transplantation * Granulocyte count less than 500/mm\^3 and profound granulocytopenia expected to last for greater than 5 days * Fever (greater than 38.5 degrees C) refractory for greater than 72 hours and less than 84 hours to broad spectrum antimicrobials, after exclusion of current bacterial, fungal, viral, parasitic, and mycobacterial infections * Peripheral blood cultures and central venous catheter cultures negative for infections * No microbiological documentation of a bacterial infection (e.g., abscess at catheter site) * No invasive fungal infection * No probable noninfectious cause of fever PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Karnofsky 40-100% OR * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Not specified Renal: * Not specified Other: * No prior anaphylactic reaction to amphotericin B * No psychological, familial, sociological, or geographical conditions that would prevent compliance * Not pregnant or nursing * Normal chest X-ray or normal high resolution CT scan of the lungs PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent active systemic antifungal agents or antifungal prophylaxis (e.g., azoles or polyenes) * No prior IV amphotericin B during same neutropenic episode * No change in antibacterial regimen within 48 hours prior to study

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

Sponsors & Collaborators

Study Sites (24)

A.Z. St. Jan

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Clinique Universitaire De Mont-Godinne

Mont-Godinne Yvoir, 5530, Belgium

Location

University Hospital - Olomouc

Olomouc, 775 20, Czechia

Location

CHU de Caen

Caen, 14033, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Universitaetsklinikum Charite

Berlin, D-10117, Germany

Location

Virchow Klinikum Humboldt Universitaet Berlin

Berlin, D-13353, Germany

Location

Athens University-Laikon General Hospital

Athens, 11527, Greece

Location

Hippokration Hospital

Thessaloniki, 54642, Greece

Location

Szent Laszlo Korhaz

Budapest, 1097, Hungary

Location

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa (Genova), 16132, Italy

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Hospital De Santo Antonio Dos Capuchos

Lisbon (Lisboa), 1100, Portugal

Location

National Cancer Institute - Bratislava

Bratislava, 812 50, Slovakia

Location

Hospital de la Santa Cruz I Sant Pau

Barcelona, 08025, Spain

Location

Hospital Central de Asturias

Oviedo, 33006, Spain

Location

Huddinge University Hospital

Stockholm, SE-141 86, Sweden

Location

Section of Infectious Diseases

Ankara, 06100, Turkey (Türkiye)

Location

Tawam Hospital

Abu Dhabi, United Arab Emirates

Location

MeSH Terms

Conditions

NeoplasmsHodgkin DiseaseBreast NeoplasmsMonoclonal Gammopathy of Undetermined SignificancePrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousMultiple MyelomaCarcinoma, Ovarian EpithelialNeuroblastomaWilms TumorLeukemia, Lymphocytic, Chronic, B-CellWaldenstrom MacroglobulinemiaLeukemia, Myeloid, AcuteTesticular NeoplasmsLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisPolycythemia VeraPrimary MyelofibrosisThrombocythemia, EssentialFeverHot FlashesTeratoma, TesticularEndodermal Sinus TumorTeratomaSeminomaCarcinoma, EmbryonalLeukemia, Hairy CellRecurrenceLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaLeukemia, Myelomonocytic, ChronicLeukemia, Large Granular LymphocyticLeukemia, Biphenotypic, AcutePrecursor T-Cell Lymphoblastic Leukemia-LymphomaNeutropeniaInfectionsLeukemia, ProlymphocyticImmunoglobulin Light-chain AmyloidosisIntraocular LymphomaDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromePdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Neutrophilic, ChronicLymphoma, B-Cell, Marginal Zone

Interventions

liposomal amphotericin B

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHypergammaglobulinemiaBlood Protein DisordersHematologic DiseasesParaproteinemiasLeukemia, LymphoidLeukemiaLymphoma, T-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic 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 ProcessesBone Marrow NeoplasmsHematologic NeoplasmsBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersBody Temperature ChangesSigns and SymptomsMesonephromaGerminomaLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsMyelodysplastic-Myeloproliferative DiseasesLeukemia, T-CellAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesEye NeoplasmsHistiocytic Disorders, MalignantHistiocytosisLymphadenopathy

Study Officials

  • P. Ljungman, MD

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

June 1, 1999

Primary Completion

May 1, 2003

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

DE(2)AE(1)BE(5)IL(1)HU(1)GR(2)FR(3)ES(2)SE(1)CZ(1)NL(1)SL(1)IT(1)TU(1)PT(1)