NCT00008359

Brief Summary

RATIONALE: Caspofungin acetate or amphotericin B liposomal may be effective in preventing or controlling fever and neutropenia caused by chemotherapy, bone marrow transplantation, or peripheral stem cell transplantation. It is not yet known whether caspofungin acetate or amphotericin B liposomal is more effective for treating these side effects. PURPOSE: Randomized phase III trial to compare the effectiveness of caspofungin acetate with that of amphotericin B liposomal in treating patients who have persistent fever and neutropenia after receiving anticancer therapy.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

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

August 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 4, 2003

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

2.6 years

First QC Date

January 6, 2001

Last Update Submit

January 17, 2013

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 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 myelomastage 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 chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic 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 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 remissionpolycythemia veraprimary myelofibrosisessential thrombocythemiafever, sweats, and hot flashestesticular 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 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/lymphomasecondary acute myeloid leukemiade novo myelodysplastic syndromeshigh risk metastatic gestational trophoblastic tumorpreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesprimary central nervous system non-Hodgkin lymphomaneutropeniainfectionprolymphocytic leukemiaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaprimary systemic amyloidosisintraocular 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 lymphomastage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromenoncontiguous 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 lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomachildhood myelodysplastic syndromes

Interventions

caspofungin acetateDRUG
liposomal amphotericin BDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Leukemia, lymphoma, or other cancer that has been previously treated with chemotherapy or bone marrow or peripheral blood stem cell transplantation * Absolute neutrophil count less than 500/mm\^3 for past 96 hours and not expected to recover in next 48 hours * Received at least 96 hours of parenteral systemic antibacterial therapy * Fever greater than 38.0 degrees Celsius * Adequately managed bacterial infection allowed if all of the following are true: * Negative blood cultures * Received at least 5 days of antibiotics to which any bacterial isolates are sensitive * Surgical drainage of any abscess fluid or surgical debridement of infected tissues * Removal of infected catheters * No invasive fungal infection * Not previously enrolled on this study PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * Karnofsky 30-100% Life expectancy: * At least 5 days Hematopoietic: * Platelet count at least 5,000/mm\^3 * INR no greater than 1.6 (no greater than 4.0 if receiving anticoagulants) Hepatic: * Bilirubin no greater than 3 times upper limit of normal (ULN) * AST or ALT no greater than 5 times ULN * Alkaline phosphatase no greater than 3 times ULN * No acute hepatitis or cirrhosis Renal: * Not specified Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No allergy, hypersensitivity, or prior serious reaction to any echinocandin antifungal or amphotericin B formulation * No other condition or illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics * No concurrent investigational antineoplastic therapy Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * At least 10 days since prior parenteral amphotericin B * At least 14 days since prior investigational antibiotic, antifungal, or immunosuppressive drug * No concurrent rifampin or cyclosporine * No other concurrent investigational antibiotic, antifungal, or immunosuppressive drug * No concurrent alcohol

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Walsh TJ, Teppler H, Donowitz GR, Maertens JA, Baden LR, Dmoszynska A, Cornely OA, Bourque MR, Lupinacci RJ, Sable CA, dePauw BE. Caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia. N Engl J Med. 2004 Sep 30;351(14):1391-402. doi: 10.1056/NEJMoa040446.

    PMID: 15459300RESULT

MeSH Terms

Conditions

NeoplasmsHodgkin DiseaseBreast NeoplasmsMonoclonal Gammopathy of Undetermined SignificanceLymphoma, T-Cell, CutaneousMultiple MyelomaCarcinoma, Ovarian EpithelialNeuroblastomaWilms TumorLeukemia, Lymphocytic, Chronic, B-CellWaldenstrom MacroglobulinemiaLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaTesticular NeoplasmsLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisPolycythemia VeraPrimary MyelofibrosisThrombocythemia, EssentialFeverHot FlashesTeratoma, TesticularEndodermal Sinus TumorTeratomaSeminomaCarcinoma, EmbryonalLeukemia, Hairy CellLymphoma, 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 LymphomaLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal Zone

Interventions

Caspofunginliposomal 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 DiseasesParaproteinemiasLymphoma, 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-CellLeukemia, LymphoidLeukemiaChronic 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 NeoplasmsLymphadenopathy

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Kent Sepkowitz, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 6, 2001

First Posted

September 4, 2003

Study Start

August 1, 2000

Primary Completion

March 1, 2003

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

US(1)