Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions
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Not Enrolling
Both
Cancer
Both
Cancer
Trial Information
Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions
OBJECTIVES:
Primary
- Compare the incidence of catheter-related infections (Staphylococcal and Candida) in
patients at high risk for a catheter-related infection treated with heparin vs
minocycline hydrochloride and edetate calcium disodium (M-EDTA).
Secondary
- Compare the incidence of catheter occlusions in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, prospective, multicenter study. Patients are
stratified according to type of catheter (tunneled central venous catheter [CVC] vs
nontunneled percutaneous CVC) and participating center. Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive minocycline hydrochloride and edetate calcium disodium (M-EDTA)
flush solution into the CVC once daily.
- Arm II: Patients receive heparin flush solution into the CVC once daily. Treatment in
both arms continues for up to 3 months in the absence of unacceptable toxicity or until
the removal of the catheter.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Incidence of catheter-related infections during the study period (3 months)
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Jorge Cortes, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
ID93-004
NCT ID:
NCT00378781
Start Date:
Completion Date:
Related Keywords:
- Cancer
- infection
- poor vascular access
- thromboembolism
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult 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 leukemia
- adult acute lymphoblastic leukemia in remission
- adult acute myeloid leukemia in remission
- atypical chronic myeloid leukemia, BCR-ABL negative
- blastic phase chronic myelogenous leukemia
- childhood acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- childhood chronic myelogenous leukemia
- chronic eosinophilic leukemia
- primary myelofibrosis
- chronic myelomonocytic leukemia
- chronic neutrophilic leukemia
- chronic phase chronic myelogenous leukemia
- de novo myelodysplastic syndromes
- disseminated neuroblastoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- juvenile myelomonocytic leukemia
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- nodal marginal zone B-cell lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- poor prognosis metastatic gestational trophoblastic tumor
- previously treated myelodysplastic syndromes
- recurrent adult acute lymphoblastic leukemia
- recurrent adult acute myeloid leukemia
- recurrent adult Burkitt lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent breast cancer
- recurrent/refractory childhood Hodgkin lymphoma
- recurrent childhood acute lymphoblastic leukemia
- recurrent childhood acute myeloid leukemia
- recurrent childhood large cell lymphoma
- recurrent childhood lymphoblastic lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- recurrent neuroblastoma
- recurrent ovarian epithelial cancer
- recurrent ovarian germ cell tumor
- recurrent small lymphocytic lymphoma
- recurrent malignant testicular germ cell tumor
- recurrent Wilms tumor and other childhood kidney tumors
- refractory chronic lymphocytic leukemia
- refractory hairy cell leukemia
- refractory multiple myeloma
- relapsing chronic myelogenous leukemia
- secondary acute myeloid leukemia
- secondary myelodysplastic syndromes
- splenic marginal zone lymphoma
- stage I multiple myeloma
- stage II multiple myeloma
- stage II ovarian epithelial cancer
- stage III adult Burkitt lymphoma
- stage III adult Hodgkin lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III chronic lymphocytic leukemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III multiple myeloma
- stage III ovarian epithelial cancer
- stage III small lymphocytic lymphoma
- stage III malignant testicular germ cell tumor
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV adult Burkitt lymphoma
- stage IV adult Hodgkin lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV breast cancer
- stage IV chronic lymphocytic leukemia
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV ovarian epithelial cancer
- stage IV small lymphocytic lymphoma
- acute undifferentiated leukemia
- mast cell leukemia
- stage I adult T-cell leukemia/lymphoma
- stage II adult T-cell leukemia/lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- T-cell large granular lymphocyte leukemia
- stage I chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- meningeal chronic myelogenous leukemia
- prolymphocytic leukemia
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage I childhood Hodgkin lymphoma
- stage II childhood Hodgkin lymphoma
- stage III childhood Hodgkin lymphoma
- stage IV childhood Hodgkin lymphoma
- anaplastic large cell lymphoma
- angioimmunoblastic T-cell lymphoma
- stage I mycosis fungoides/Sezary syndrome
- stage II mycosis fungoides/Sezary syndrome
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage II cutaneous T-cell non-Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- adult grade III lymphomatoid granulomatosis
- recurrent adult grade III lymphomatoid granulomatosis
- childhood grade III lymphomatoid granulomatosis
- recurrent childhood grade III lymphomatoid granulomatosis
- Waldenstrom macroglobulinemia
- stage I adult Burkitt lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I adult lymphoblastic lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I grade 3 follicular lymphoma
- stage I mantle cell lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
- contiguous stage II mantle cell lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- stage I childhood large cell lymphoma
- stage II childhood large cell lymphoma
- stage III childhood large cell lymphoma
- stage IV childhood large cell lymphoma
- stage I childhood lymphoblastic lymphoma
- stage II childhood lymphoblastic lymphoma
- stage III childhood lymphoblastic lymphoma
- stage IV childhood lymphoblastic lymphoma
- stage I childhood small noncleaved cell lymphoma
- stage II childhood small noncleaved cell lymphoma
- stage III childhood small noncleaved cell lymphoma
- stage IV childhood small noncleaved cell lymphoma
- primary central nervous system non-Hodgkin lymphoma
- post-transplant lymphoproliferative disorder
- intraocular lymphoma
- stage I melanoma
- stage II melanoma
- stage III melanoma
- stage IV melanoma
- recurrent melanoma
- unspecified adult solid tumor, protocol specific
- unspecified childhood solid tumor, protocol specific
- stage I adult soft tissue sarcoma
- stage II adult soft tissue sarcoma
- stage III adult soft tissue sarcoma
- stage IV adult soft tissue sarcoma
- recurrent adult soft tissue sarcoma
- metastatic childhood soft tissue sarcoma
- nonmetastatic childhood soft tissue sarcoma
- recurrent childhood soft tissue sarcoma
- localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
- metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
- recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
- previously treated childhood rhabdomyosarcoma
- previously untreated childhood rhabdomyosarcoma
- recurrent childhood rhabdomyosarcoma
- recurrent uterine sarcoma
- stage I uterine sarcoma
- stage II uterine sarcoma
- stage III uterine sarcoma
- stage IV uterine sarcoma
- localized osteosarcoma
- metastatic osteosarcoma
- recurrent osteosarcoma
- chondrosarcoma
- small intestine leiomyosarcoma
- recurrent small intestine cancer
- childhood myelodysplastic syndromes
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Catheter-Related Infections
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