NCT00110045

Brief Summary

RATIONALE: Antifungals, such as caspofungin acetate, may be effective in treating fungal infections caused by chemotherapy or stem cell transplant. PURPOSE: This phase II trial is studying how well caspofungin acetate works as first-line treatment for aspergillosis in patients with hematologic cancer or in patients who have undergone a stem cell transplant.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
171

participants targeted

Target at P75+ for phase_2 cancer

Geographic Reach
7 countries

13 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

February 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

3.1 years

First QC Date

May 3, 2005

Last Update Submit

September 20, 2012

Conditions

Cancer

Keywords

infectionataxia-telangiectasiaaccelerated phase chronic myelogenous leukemiaacute undifferentiated leukemiablastic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiarelapsing chronic myelogenous leukemiachronic eosinophilic leukemiaprimary myelofibrosischronic neutrophilic leukemiaessential thrombocythemiapolycythemia veraadult acute lymphoblastic leukemia in remissionrecurrent adult acute lymphoblastic leukemiaadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)adult acute myeloid leukemia in remissionrecurrent adult T-cell leukemia/lymphomastage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarefractory chronic lymphocytic leukemiastage 0 chronic lymphocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiaprogressive hairy cell leukemia, initial treatmentrefractory hairy cell leukemiaprolymphocytic leukemiarecurrent adult Hodgkin lymphomastage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomarecurrent mycosis fungoides/Sezary syndromestage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent cutaneous T-cell non-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 lymphomaadult grade III lymphomatoid granulomatosisrecurrent adult grade III lymphomatoid granulomatosisWaldenstrom macroglobulinemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomacontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult Burkitt lymphomastage I adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomacontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomastage I adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomastage I adult diffuse mixed cell lymphomastage III adult diffuse mixed cell lymphomastage IV adult diffuse mixed cell lymphomacontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomastage I adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II adult lymphoblastic lymphomastage I adult lymphoblastic lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomacontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomastage I grade 1 follicular lymphomastage III grade 1 follicular lymphomastage IV grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomastage I grade 2 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomastage I grade 3 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 3 follicular lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphomastage I mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomacontiguous stage II marginal zone lymphomanoncontiguous stage II marginal zone lymphomastage I marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomasplenic marginal zone lymphomacontiguous stage II small lymphocytic lymphomanoncontiguous stage II small lymphocytic lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomaintraocular lymphomaprimary central nervous system non-Hodgkin lymphomapost-transplant lymphoproliferative disorderextramedullary plasmacytomaisolated plasmacytoma of bonemonoclonal gammopathy of undetermined significancestage I multiple myelomastage II multiple myelomastage III multiple myelomaprimary systemic amyloidosisrefractory multiple myelomade novo myelodysplastic syndromesmyelodysplastic/myeloproliferative neoplasm, unclassifiablepreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesatypical chronic myeloid leukemia, BCR-ABL1 negativechronic myelomonocytic leukemiadisseminated neuroblastomahigh risk metastatic gestational trophoblastic tumorrecurrent neuroblastomarecurrent ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian germ cell tumorrecurrent malignant testicular germ cell tumorstage III malignant testicular germ cell tumorsecondary acute myeloid leukemiastage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerchronic phase chronic myelogenous leukemiacontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomarecurrent adult acute myeloid leukemiastage I adult diffuse small cleaved cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomaT-cell large granular lymphocyte leukemia

Outcome Measures

Primary Outcomes (1)

  • Response rate as assessed by standard criteria after completion of study treatment

Secondary Outcomes (3)

  • Response rate as assessed by standard and alternative criteria at 84 days and after completion of study treatment

  • Survival rate at 84 days

  • Safety

Interventions

caspofungin acetateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of proven or probable invasive aspergillosis (IA) * Patients with a diagnosis of possible IA are eligible provided they are upgraded to probable or proven IA by culture and/or histology results and Aspergillus galactomannan evaluation within 7 days after study entry * Meets any of the following criteria: * Diagnosis of a hematologic malignancy * Underwent autologous or allogeneic hematopoietic stem cell transplantation PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 20-100% Life expectancy * Not specified Hematopoietic * Not specified Hepatic * AST and ALT ≤ 5 times upper limit of normal (ULN) * Bilirubin ≤ 5 times ULN * Alkaline phosphatase ≤ 5 times ULN * No severe hepatic insufficiency * Child-Pugh score ≤ 9 Renal * No severe renal failure requiring hemodialysis or peritoneal dialysis * Creatinine \< 3.4 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception * No known HIV positivity * No history of allergy or adverse reaction to echinocandin drugs * No known bacterial infection that is not adequately treated * No psychological, familial, social, or geographical condition that would preclude study participation or compliance PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * Prior empirical antifungal therapy allowed provided treatment duration was ≤ 72 hours * Prior prophylactic oral antifungals allowed * Prior prophylactic IV fluconazole allowed * More than 14 days since prior and no concurrent investigational agents * No prior participation in this study * No prior echinocandins * No other concurrent antifungal therapy

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

Sponsors & Collaborators

Study Sites (13)

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, B-4000, Belgium

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Hopital Edouard Herriot - Lyon

Lyon, 69437, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Hopital Universitaire Hautepierre

Strasbourg, 67098, France

Location

Medizinische Poliklinik, Universitaet Wuerzburg

Würzburg, D-97070, Germany

Location

Ospedale Santa Croce

Cuneo, 12100, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

Location

Ospedale San Martino

Genoa, 16132, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

National Cancer Institute - Bratislava

Bratislava, 833 10, Slovakia

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Hacettepe University - Faculty of Medicine

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Viscoli C, Herbrecht R, Akan H, Baila L, Sonet A, Gallamini A, Giagounidis A, Marchetti O, Martino R, Meert L, Paesmans M, Ameye L, Shivaprakash M, Ullmann AJ, Maertens J; Infectious Disease Group of the EORTC. An EORTC Phase II study of caspofungin as first-line therapy of invasive aspergillosis in haematological patients. J Antimicrob Chemother. 2009 Dec;64(6):1274-81. doi: 10.1093/jac/dkp355. Epub 2009 Oct 19.

    PMID: 19841031RESULT

MeSH Terms

Conditions

NeoplasmsInfectionsAtaxia TelangiectasiaLeukemia, Myeloid, Accelerated PhaseLeukemia, Biphenotypic, AcuteBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Neutrophilic, ChronicThrombocythemia, EssentialPolycythemia VeraPrecursor Cell Lymphoblastic Leukemia-LymphomaCongenital AbnormalitiesPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellLeukemia, ProlymphocyticHodgkin DiseaseLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyMycosis FungoidesSezary SyndromeLymphoma, T-Cell, CutaneousWaldenstrom MacroglobulinemiaLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellIntraocular LymphomaMonoclonal Gammopathy of Undetermined SignificanceMultiple MyelomaImmunoglobulin Light-chain AmyloidosisMyeloproliferative DisordersLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeLeukemia, Myelomonocytic, ChronicNeuroblastomaCarcinoma, Ovarian EpithelialTesticular NeoplasmsBreast NeoplasmsLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, AcuteLeukemia, Large Granular Lymphocytic

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Spinocerebellar AtaxiasCerebellar AtaxiaCerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocutaneous SyndromesAtaxiaDyskinesiasNeurologic ManifestationsTelangiectasisVascular DiseasesCardiovascular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPrimary Immunodeficiency DiseasesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesImmunologic Deficiency SyndromesImmune System DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic DisordersBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteLeukemia, B-CellLymphomaLymphoma, T-CellLymphadenopathyNeoplasms, Plasma CellHemostatic DisordersParaproteinemiasBlood Protein DisordersLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsEye NeoplasmsHypergammaglobulinemiaAmyloidosisProteostasis DeficienciesMyelodysplastic-Myeloproliferative DiseasesNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCarcinomaOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeukemia, T-Cell

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Claudio Viscoli, MD

    IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2005

First Posted

May 4, 2005

Study Start

February 1, 2005

Primary Completion

March 1, 2008

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

FR(4)IT(4)SL(1)TU(1)CH(1)DE(1)BE(1)