NCT00324324

Brief Summary

RATIONALE: A donor stem cell transplant can lower the body's immune system, making it difficult to fight off infection. Giving antibiotics, such as moxifloxacin, may help prevent bacterial infections in patients who have recently undergone donor stem cell transplant. It is not yet known whether moxifloxacin is more effective than a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant. PURPOSE: This randomized phase III trial is studying moxifloxacin to see how well it works compared with a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
240

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started May 2006

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

May 10, 2006

Last Update Submit

May 7, 2017

Conditions

Breast CancerChronic Myeloproliferative DisordersGestational Trophoblastic TumorInfectionLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsNeuroblastomaOvarian CancerTesticular Germ Cell Tumor

Keywords

infectionadult 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)accelerated phase chronic myelogenous leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionatypical chronic myeloid leukemia, BCR-ABL negativeblastic phase chronic myelogenous leukemiachronic eosinophilic leukemiaprimary myelofibrosischronic myelomonocytic leukemiachronic neutrophilic leukemiachronic phase chronic myelogenous leukemiade novo myelodysplastic syndromesdisseminated neuroblastomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuemyelodysplastic/myeloproliferative neoplasm, unclassifiablenodal marginal zone B-cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous 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 mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomapoor prognosis metastatic gestational trophoblastic tumorpreviously treated myelodysplastic syndromesrecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent adult Burkitt lymphomarecurrent adult Hodgkin 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 cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent neuroblastomarecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorrecurrent small lymphocytic lymphomarecurrent malignant testicular germ cell tumorrefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarefractory multiple myelomarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiasecondary myelodysplastic syndromessplenic marginal zone lymphomastage I multiple myelomastage II multiple myelomastage II ovarian epithelial cancerstage III adult Burkitt lymphomastage III adult Hodgkin lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III chronic lymphocytic leukemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III multiple myelomastage III ovarian epithelial cancerstage III small lymphocytic lymphomastage III malignant testicular germ cell tumorstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV adult Burkitt lymphomastage IV adult Hodgkin lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV breast cancerstage IV chronic lymphocytic leukemiastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV ovarian epithelial cancerstage IV small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    1 to 120 days post bone marrow transplant

Secondary Outcomes (4)

  • Incidence of bacteremia

    1 to 120 days post bone marrow transplant

  • Incidence and severity of graft-versus-host disease

    1 to 120 days post bone marrow transplant

  • Infection-related mortality

    1 to 120 days post bone marrow transplant

  • Overall mortality

    1 to 120 days post bone marrow transplant

Study Arms (2)

moxifloxacin hydrochloride

ACTIVE COMPARATOR

Moxifloxacin 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue

Drug: moxifloxacin hydrochloride

Sugar pill

PLACEBO COMPARATOR

Placebo 1 capsule orally once a day through D+100 after bone marrow transplant, then discontinue

Drug: Placebo

Interventions

moxifloxacin hydrochlorideDRUG

Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue

moxifloxacin hydrochloride
PlaceboDRUG

Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue

Sugar pill

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Must be planning to undergo or have completed allogeneic stem cell transplantation (ASCT) * Must not be undergoing a nonmyeloablative ASCT * Must not require antibiotic prophylaxis against bacterial pathogens during the post-engraftment phase as per ASCT protocol * No known colonization with an antimicrobial-resistant organism normally sensitive to quinolones that is known to increase infection incidence (i.e., ciprofloxacin-resistant Pseudomonas not allowed; vancomycin-resistant Enterococcus and methicillin-resistant Staphylococcus aureus allowed) PATIENT CHARACTERISTICS: * Life expectancy ≥ 100 days * Not pregnant or nursing * Fertile patients must use effective contraception * Negative pregnancy test * No known hypersensitivity to fluoroquinolones * No prolonged QTc interval on EKG (i.e., QTc \> 440 milliseconds) * No uncontrolled hypokalemia PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent class IA (e.g., quinidine or procainamide) or class III (e.g., amiodarone or sotalol) antiarrhythmics * No concurrent intravenous antibiotics for pre-enrollment infections except vancomycin, linezolid, dalfopristin, or quinupristin (Synercid®)

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

Sponsors & Collaborators

Study Sites (1)

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Related Publications (1)

  • Bubalo JS, Leis JF, Curtin PT, et al.: A randomized, double-blinded, pilot trial of aprepitant added to standard antiemetics during conditioning therapy for hematopoietic stem cell transplant (HSCT). [Abstract] J Clin Oncol 25 (Suppl 18): A-9112, 520s, 2007.

    RESULT

MeSH Terms

Conditions

Breast NeoplasmsMyeloproliferative DisordersGestational Trophoblastic DiseaseInfectionsLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesNeuroblastomaOvarian NeoplasmsTesticular Germ Cell TumorCongenital AbnormalitiesLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic-PhaseLymphoma, B-Cell, Marginal ZonePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteBurkitt LymphomaHodgkin DiseaseLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeCarcinoma, Ovarian EpithelialLeukemia, Lymphocytic, Chronic, B-CellTesticular NeoplasmsLeukemia, Hairy Cell

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesTrophoblastic NeoplasmsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypePregnancy Complications, NeoplasticPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellLeukemia, LymphoidEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsLymphoma, T-CellCarcinomaLeukemia, B-CellGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Joseph Bubalo, PharmD, BCPS, BCOP

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 11, 2006

Study Start

May 1, 2006

Primary Completion

April 1, 2007

Study Completion

December 1, 2012

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

US(1)