NCT00378781

Brief Summary

RATIONALE: Heparin or M-EDTA may prevent catheter-related infections and blockages in patients at high risk for a catheter-related infection. It is not yet known whether heparin is more effective than M-EDTA in preventing catheter-related infections and blockages in patients at high risk for a catheter-related infection. PURPOSE: This randomized clinical trial is studying heparin to see how well it works compared with M-EDTA in preventing catheter-related infections and blockages in patients at high risk for a catheter-related infection.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
Last Updated

February 24, 2012

Status Verified

February 1, 2012

First QC Date

September 19, 2006

Last Update Submit

February 22, 2012

Conditions

Cancer

Keywords

infectionpoor vascular accessthromboembolismadult 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 leukemiachildhood acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood 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 tissuejuvenile myelomonocytic leukemiamyelodysplastic/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 breast cancerrecurrent/refractory childhood Hodgkin lymphomarecurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell 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 tumorrecurrent Wilms tumor and other childhood kidney tumorsrefractory 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 lymphomaacute undifferentiated leukemiamast cell leukemiastage 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/lymphomaT-cell large granular lymphocyte leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiameningeal chronic myelogenous leukemiaprolymphocytic leukemiastage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage I childhood Hodgkin lymphomastage II childhood Hodgkin lymphomastage III childhood Hodgkin lymphomastage IV childhood Hodgkin lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomastage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromestage 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 granulomatosischildhood grade III lymphomatoid granulomatosisrecurrent childhood grade III lymphomatoid granulomatosisWaldenstrom macroglobulinemiastage I adult Burkitt lymphomastage I adult diffuse large cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse small cleaved cell lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I mantle cell lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomacontiguous stage II adult Burkitt lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult lymphoblastic lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II mantle cell lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomastage I childhood large cell lymphomastage II childhood large cell lymphomastage III childhood large cell lymphomastage IV childhood large cell lymphomastage I childhood lymphoblastic lymphomastage II childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomastage I childhood small noncleaved cell lymphomastage II childhood small noncleaved cell lymphomastage III childhood small noncleaved cell lymphomastage IV childhood small noncleaved cell lymphomaprimary central nervous system non-Hodgkin lymphomapost-transplant lymphoproliferative disorderintraocular lymphomastage I melanomastage II melanomastage III melanomastage IV melanomarecurrent melanomaunspecified adult solid tumor, protocol specificunspecified childhood solid tumor, protocol specificstage I adult soft tissue sarcomastage II adult soft tissue sarcomastage III adult soft tissue sarcomastage IV adult soft tissue sarcomarecurrent adult soft tissue sarcomametastatic childhood soft tissue sarcomanonmetastatic childhood soft tissue sarcomarecurrent childhood soft tissue sarcomalocalized Ewing sarcoma/peripheral primitive neuroectodermal tumormetastatic Ewing sarcoma/peripheral primitive neuroectodermal tumorrecurrent Ewing sarcoma/peripheral primitive neuroectodermal tumorpreviously treated childhood rhabdomyosarcomapreviously untreated childhood rhabdomyosarcomarecurrent childhood rhabdomyosarcomarecurrent uterine sarcomastage I uterine sarcomastage II uterine sarcomastage III uterine sarcomastage IV uterine sarcomalocalized osteosarcomametastatic osteosarcomarecurrent osteosarcomachondrosarcomasmall intestine leiomyosarcomarecurrent small intestine cancerchildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Incidence of catheter-related infections during the study period (3 months)

    3 months

Secondary Outcomes (1)

  • Incidence of catheter occlusions during periods of prophylaxis (e.g., time period in which the catheter is locked with heparin or minocycline hydrochloride and edetate calcium disodium [M-EDTA])

    3 months

Study Arms (2)

Arm I

EXPERIMENTAL

Minocycline hydrochloride + Edetate Calcium Disodium (M-EDTA) flush solution into CVC once daily.

Drug: Minocycline-EDTA

Arm II

EXPERIMENTAL

Heparin flush solution into CVC once daily.

Drug: Heparin

Interventions

HeparinDRUG

Heparin flush solution into CVC once daily.

Also known as: Hep-Lock
Arm II
Minocycline-EDTADRUG

M-EDTA flush solution into CVC once daily.

Also known as: Minocycline hydrochloride, Edetate Calcium Disodium, M-EDTA
Arm I

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * At high risk of acquiring a catheter infection, as evidenced by any of the following: * Diagnosis of leukemia, lymphoma, myeloma, or melanoma-sarcoma * Undergoing hematopoietic stem cell transplantation * Receiving aldesleukin * Pediatric cancer patients * New (≤ 10 days old) functioning externalized tunneled or nontunneled central venous catheter (CVC), such as a Hickman/Broviac or Hohn catheter, or peripherally inserted central venous catheter (PICC) utilized for infusion of chemotherapy, blood and blood products, or other intermittent infusions * No occluded CVC * No existing local or systemic catheter infection * More than 3 days since removal of a prior CVC due to an infection * No externalized CVC that is projected to remain in place for \< 2 weeks * No infusion ports or Groshong catheters * No coated CVC impregnated with an antimicrobial or antiseptic agent PATIENT CHARACTERISTICS: * Life expectancy ≥ 3 months * No history of allergy to any tetracycline * No contraindication to flush solution dwell time of ≥ 4 hours * No hypocalcemia while receiving calcium supplementation through the catheter * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

NeoplasmsInfectionsThromboembolismCongenital AbnormalitiesLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelomonocytic, JuvenileMyeloproliferative DisordersLymphoma, B-Cell, Marginal ZonePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteBurkitt LymphomaHodgkin DiseaseLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticBreast NeoplasmsRecurrenceDendritic Cell Sarcoma, InterdigitatingLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeNeuroblastomaCarcinoma, Ovarian EpithelialLeukemia, Lymphocytic, Chronic, B-CellTesticular NeoplasmsWilms TumorLeukemia, Hairy CellMultiple MyelomaLeukemia, Biphenotypic, AcuteLeukemia, Mast-CellPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Large Granular LymphocyticLeukemia, ProlymphocyticLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyWaldenstrom MacroglobulinemiaIntraocular LymphomaMelanomaSarcomaNeuroectodermal Tumors, Primitive, PeripheralOsteosarcomaChondrosarcoma

Interventions

HeparinMinocyclinePentetic Acid

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyelodysplastic-Myeloproliferative DiseasesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellLymphomaLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHistiocytic Disorders, MalignantHistiocytosisLymphoma, T-CellNeuroectodermal 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 DisordersLeukemia, B-CellGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular DiseasesNeoplasms, Complex and MixedKidney NeoplasmsUrologic NeoplasmsNeoplastic Syndromes, HereditaryKidney DiseasesUrologic DiseasesGenetic Diseases, InbornNeoplasms, Plasma CellHemostatic DisordersParaproteinemiasBlood Protein DisordersHemorrhagic DisordersMastocytosis, SystemicMastocytosisMast Cell Activation DisordersLeukemia, T-CellLymphadenopathyEye NeoplasmsNeuroendocrine TumorsNevi and MelanomasSkin NeoplasmsNeoplasms, Connective and Soft TissueNeoplasms, Bone TissueNeoplasms, Connective Tissue

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsPolyaminesAminesAcetatesAcids, AcyclicCarboxylic Acids

Study Officials

  • Jorge Cortes, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2006

First Posted

September 21, 2006

Last Updated

February 24, 2012

Record last verified: 2012-02